Back to resultsAn Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect (ADIPOSTRESS)
Primary Purpose
Obesity, Weight Loss, Diet
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Meal replacement diet using Modifast
Normal diet combined with Modifast diet
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Adipocytes
Eligibility Criteria
Inclusion Criteria:
- Age (years): 20-65
- Body Mass Index (kg/m2): 28-35
- Non-smokers
Exclusion Criteria:
- Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1)
- marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female)
- planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator;
- blood donation within the past 2 months prior to the study
- weight change of >3 kg within 2 months prior to the study
- psychiatric disease (based on medical history only)
- pregnant or lactating women, or women planning to become pregnant within the next 12 months
- surgically treated obesity
- participation in other clinical studies within the last 3 months
- drug abuse (based on clinical judgment)
- unable to give informed consent
- unable to engage in a low-calorie diet
- unable to lose more then 8% of body weight after weight-loss period
- following a special diet (vegetarian, Atkins or other).
Sites / Locations
- Maastricht University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Very Low Calorie Diet
Low Calorie Diet
Arm Description
1250 kcal diet in which Modifast is given in combination with a normal diet
Outcomes
Primary Outcome Measures
change in weight following weight loss
VLCD diet group
change in weight following weight loss
LCD diet group
Secondary Outcome Measures
change in adipokine profile due to dietary intervention (VLCD-group)
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
change in adipokine during weight stable-period (VLCD-group)
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
change in adipokine profile during follow-up (VLCD-group)
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
change in adipokine profile due to dietary intervention (LCD-group)
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
change in adipokine profile during weight-stable period (LCD-group)
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
change in adipokine profile during follow-up (LCD-group)
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Changes in adipokine profile in the LCD-group compared to the VLCD-group
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
change in adipokine profile in relation to weight regain during follow-up
In LCD-group and VLCD-group
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
change in parameters of adipocyte fat metabolism due to dietary intervention (VLCD-group)
In VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
change in parameters of adipocyte fat metabolism during weight-stable period (VLCD-group)
In VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
change in parameters of adipocyte fat metabolism during follow-up period (VLCD-group)
In VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
change in parameters of adipocyte fat metabolism due to dietary intervention (LCD-group)
In LCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
change in parameters of adipocyte fat metabolism during weight-stable period (LCD-group)
In LCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
change in parameters of adipocyte fat metabolism during follow-up (LCD-group)
In LCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Changes in parameters of adipocyte fat metabolism in the LCD-group compared to the VLCD-group
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
change in parameters of adipocyte fat metabolism in relation to weight regain during follow-up
In LCD-group and VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
change in in-vivo adipose tissue metabolism due to dietary intervention (VLCD-group)
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in in-vivo adipose tissue metabolism during weight-stable period (VLCD-group)
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in in-vivo adipose tissue metabolism during follow-up period (VLCD-group)
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in in-vivo adipose tissue metabolism due to dietary intervention (LCD-group)
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in in-vivo adipose tissue metabolism during weight-stable period (LCD-group)
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in in-vivo adipose tissue metabolism during follow-up period (LCD-group)
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in in-vivo adipose tissue metabolism in the LCD-group compared to the VLCD-group
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in in-vivo adipose tissue metabolism in relation to weight regain during follow-up
In LCD-group and VLCD-group
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (VLCD-group)
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (VLCD-group)
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (VLCD-group)
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (LCD-group)
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (LCD-group)
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (LCD-group)
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in the adipocyte extracellular matrix gene and protein expression profile in the LCD-group compared to the VLCD-group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in the adipocyte extracellular matrix gene and protein expression profile in relation to weight regain during follow-up
In LCD-group and VLCD-group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
change in adipocyte stress proteins expression due to dietary intervention (VLCD-group)
VLCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in adipocyte stress proteins expression during weight-stable period (VLCD-group)
VLCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in adipocyte stress proteins expression during follow-up period (VLCD-group)
VLCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in adipocyte stress proteins expression due to dietary intervention (LCD-group)
LCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in adipocyte stress proteins expression during weight-stable period (LCD-group)
LCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in adipocyte stress proteins expression during follow-up period (LCD-group)
LCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in adipocyte stress proteins expression in the LCD-group compared to the VLCD-group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in adipocyte stress proteins expression in relation to weight regain during follow-up
In LCD-group and VLCD-group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
change in physiological parameters due to dietary intervention (VLCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
change in physiological parameters during weight-stable period (VLCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
change in physiological parameters during follow-up period (VLCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
change in physiological parameters due to dietary intervention (LCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
change in physiological parameters during weight-stable period (LCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
change in physiological parameters during follow-up (LCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Changes in physiological parameters in the LCD-group compared to the VLCD-group
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Changes in physiological parameters in relation to weight regain during follow-up
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
change in plasma metabolic parameters due to dietary intervention (VLCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
change in plasma metabolic parameters during weight-stable period (VLCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
change in plasma metabolic parameters during follow-up period (VLCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
change in plasma metabolic parameters due to dietary intervention (LCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
change in plasma metabolic parameters during weight-stable period (LCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
change in plasma metabolic parameters during follow-up (LCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Changes in plasma metabolic parameters in the LCD-group compared to the VLCD-group
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Changes in plasma metabolic parameters in relation to weight regain during follow-up
In LCD-group and VLCD-group
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
change in fat cell size and fat cell number due to the dietary intervention (VLCD-group)
change in fat cell size and fat cell number during weight-stable period (VLCD-group)
change in fat cell size and fat cell number during follow-up period (VLCD-group)
change in fat cell size and fat cell number due to dietary intervention (LCD-group)
change in fat cell size and fat cell number during weight-stable period (LCD-group)
change in fat cell size and fat cell number during follow-up (LCD-group)
Changes in fat cell size and fat cell number in the LCD-group compared to the VLCD-group
Changes in fat cell size and fat cell number in relation to weight regain after weight loss
In LCD-group and VLCD-group
change in breath volatile organic compounds due to the dietary intervention (VLCD-group)
change in breath volatile organic compounds during weight-stable period (VLCD-group)
change in breath volatile organic compounds during follow-up period (VLCD-group)
change in breath volatile organic compounds due to dietary intervention (LCD-group)
change in breath volatile organic compounds during weight-stable period (LCD-group)
change in breath volatile organic compounds during follow-up (LCD-group)
Changes in breath volatile organic compounds in the LCD-group compared to the VLCD-group
Changes in breath volatile organic compounds in relation to weight regain during follow-up
In LCD-group and VLCD-group
change in inflammatory parameters due to the dietary intervention (VLCD-group)
In VLCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
change in inflammatory parameters during weight-stable period (VLCD-group)
In VLCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
change in inflammatory parameters during follow-up period (VLCD-group)
In VLCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
change in inflammatory parameters due to dietary intervention (LCD-group)
In LCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
change in inflammatory parameters during weight-stable period (LCD-group)
In LCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
change in inflammatory parameters during follow-up (LCD-group)
In LCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Changes in inflammatory parameters in the LCD-group compared to the VLCD-group
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Changes in inflammatory parameters in relation to weight regain during the follow-up
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Changes in protein concentration of metabolic parameters due to the dietary intervention (VLCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Changes in protein concentration of metabolic parameters during weight-stable period (VLCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
change in protein concentration of metabolic parameters during follow-up (VLCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
change in protein concentration of metabolic parameters due to dietary intervention (LCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
change in protein concentration of metabolic parameters during weight-stable period (LCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
change in protein concentration of metabolic parameters during follow-up (LCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
change in protein concentration of metabolic parameters in the LCD-group compared to the VLCD-group
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
change in protein concentration of metabolic parameters in relation to weight regain during follow-up
In LCD-group and VLCD-group
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Full Information
NCT ID
NCT01559415
First Posted
March 12, 2012
Last Updated
December 22, 2014
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01559415
Brief Title
An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect
Acronym
ADIPOSTRESS
Official Title
An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up period subjects will receive dietary advice according to the Dutch recommendations for healthy eating. The association between the amount of weight regain after the weight loss period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein expression and gene polymorphisms in selected genes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Diet
Keywords
Adipocytes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Very Low Calorie Diet
Arm Type
Experimental
Arm Title
Low Calorie Diet
Arm Type
Active Comparator
Arm Description
1250 kcal diet in which Modifast is given in combination with a normal diet
Intervention Type
Other
Intervention Name(s)
Meal replacement diet using Modifast
Intervention Description
modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks
Intervention Type
Other
Intervention Name(s)
Normal diet combined with Modifast diet
Intervention Description
Combination of modifast and regular diet (1250 kcal/d) for 3 months
Primary Outcome Measure Information:
Title
change in weight following weight loss
Description
VLCD diet group
Time Frame
at 9 weeks and at 46 weeks
Title
change in weight following weight loss
Description
LCD diet group
Time Frame
at 16 weeks and at 53 weeks
Secondary Outcome Measure Information:
Title
change in adipokine profile due to dietary intervention (VLCD-group)
Description
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in adipokine during weight stable-period (VLCD-group)
Description
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
after 5 weeks of VLCD diet and after 9 weeks
Title
change in adipokine profile during follow-up (VLCD-group)
Description
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in adipokine profile due to dietary intervention (LCD-group)
Description
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in adipokine profile during weight-stable period (LCD-group)
Description
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in adipokine profile during follow-up (LCD-group)
Description
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
Changes in adipokine profile in the LCD-group compared to the VLCD-group
Description
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in adipokine profile in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in parameters of adipocyte fat metabolism due to dietary intervention (VLCD-group)
Description
In VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in parameters of adipocyte fat metabolism during weight-stable period (VLCD-group)
Description
In VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in parameters of adipocyte fat metabolism during follow-up period (VLCD-group)
Description
In VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in parameters of adipocyte fat metabolism due to dietary intervention (LCD-group)
Description
In LCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in parameters of adipocyte fat metabolism during weight-stable period (LCD-group)
Description
In LCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in parameters of adipocyte fat metabolism during follow-up (LCD-group)
Description
In LCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
Changes in parameters of adipocyte fat metabolism in the LCD-group compared to the VLCD-group
Description
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in parameters of adipocyte fat metabolism in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group.
Parameters of adipocyte fat metabolism:
ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
Micro-array analysis of gene expression profile
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in in-vivo adipose tissue metabolism due to dietary intervention (VLCD-group)
Description
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in in-vivo adipose tissue metabolism during weight-stable period (VLCD-group)
Description
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in in-vivo adipose tissue metabolism during follow-up period (VLCD-group)
Description
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
at 9 weeks and after follow-up period at 46 weeks
Title
change in in-vivo adipose tissue metabolism due to dietary intervention (LCD-group)
Description
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in in-vivo adipose tissue metabolism during weight-stable period (LCD-group)
Description
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in in-vivo adipose tissue metabolism during follow-up period (LCD-group)
Description
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
at 16 weeks and after follow-up period at 53 weeks
Title
change in in-vivo adipose tissue metabolism in the LCD-group compared to the VLCD-group
Description
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in in-vivo adipose tissue metabolism in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
adipose tissue blood flow
adipose tissue PO2
adipose tissue oxygen consumption
adipose tissue capacity for fat uptake from chylomicron-triglycerides
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (VLCD-group)
Description
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (VLCD-group)
Description
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (VLCD-group)
Description
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
at 9 weeks and after follow-up period at 46 weeks
Title
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (LCD-group)
Description
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (LCD-group)
Description
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (LCD-group)
Description
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
at 16 weeks and after follow-up period
Title
change in the adipocyte extracellular matrix gene and protein expression profile in the LCD-group compared to the VLCD-group
Description
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in the adipocyte extracellular matrix gene and protein expression profile in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group
Adipocyte extracellular matrix gene expression profile assessed:
micro-arrays on RNA expression
protein expression
Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in adipocyte stress proteins expression due to dietary intervention (VLCD-group)
Description
VLCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in adipocyte stress proteins expression during weight-stable period (VLCD-group)
Description
VLCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in adipocyte stress proteins expression during follow-up period (VLCD-group)
Description
VLCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
at 9 weeks and after follow-up period at week 46
Title
change in adipocyte stress proteins expression due to dietary intervention (LCD-group)
Description
LCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in adipocyte stress proteins expression during weight-stable period (LCD-group)
Description
LCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
after 12 weeks of LCD diet and at week 16
Title
change in adipocyte stress proteins expression during follow-up period (LCD-group)
Description
LCD diet group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
at week 16 and after follow-up period at 53 weeks
Title
change in adipocyte stress proteins expression in the LCD-group compared to the VLCD-group
Description
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in adipocyte stress proteins expression in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group
Adipocyte stress proteins expression:
components of stress fibers and focal adhesions, like integrins
43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in physiological parameters due to dietary intervention (VLCD-group)
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in physiological parameters during weight-stable period (VLCD-group)
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in physiological parameters during follow-up period (VLCD-group)
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in physiological parameters due to dietary intervention (LCD-group)
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in physiological parameters during weight-stable period (LCD-group)
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in physiological parameters during follow-up (LCD-group)
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
Changes in physiological parameters in the LCD-group compared to the VLCD-group
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
Changes in physiological parameters in relation to weight regain during follow-up
Description
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in plasma metabolic parameters due to dietary intervention (VLCD-group)
Description
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in plasma metabolic parameters during weight-stable period (VLCD-group)
Description
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in plasma metabolic parameters during follow-up period (VLCD-group)
Description
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in plasma metabolic parameters due to dietary intervention (LCD-group)
Description
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in plasma metabolic parameters during weight-stable period (LCD-group)
Description
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in plasma metabolic parameters during follow-up (LCD-group)
Description
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
Changes in plasma metabolic parameters in the LCD-group compared to the VLCD-group
Description
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
Changes in plasma metabolic parameters in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in fat cell size and fat cell number due to the dietary intervention (VLCD-group)
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in fat cell size and fat cell number during weight-stable period (VLCD-group)
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in fat cell size and fat cell number during follow-up period (VLCD-group)
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in fat cell size and fat cell number due to dietary intervention (LCD-group)
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in fat cell size and fat cell number during weight-stable period (LCD-group)
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in fat cell size and fat cell number during follow-up (LCD-group)
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
Changes in fat cell size and fat cell number in the LCD-group compared to the VLCD-group
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
Changes in fat cell size and fat cell number in relation to weight regain after weight loss
Description
In LCD-group and VLCD-group
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in breath volatile organic compounds due to the dietary intervention (VLCD-group)
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in breath volatile organic compounds during weight-stable period (VLCD-group)
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in breath volatile organic compounds during follow-up period (VLCD-group)
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in breath volatile organic compounds due to dietary intervention (LCD-group)
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in breath volatile organic compounds during weight-stable period (LCD-group)
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in breath volatile organic compounds during follow-up (LCD-group)
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
Changes in breath volatile organic compounds in the LCD-group compared to the VLCD-group
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
Changes in breath volatile organic compounds in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in inflammatory parameters due to the dietary intervention (VLCD-group)
Description
In VLCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
change in inflammatory parameters during weight-stable period (VLCD-group)
Description
In VLCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in inflammatory parameters during follow-up period (VLCD-group)
Description
In VLCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in inflammatory parameters due to dietary intervention (LCD-group)
Description
In LCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in inflammatory parameters during weight-stable period (LCD-group)
Description
In LCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in inflammatory parameters during follow-up (LCD-group)
Description
In LCD-group.
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
Changes in inflammatory parameters in the LCD-group compared to the VLCD-group
Description
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
Changes in inflammatory parameters in relation to weight regain during the follow-up
Description
Inflammatory parameters are analyzed in:
Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
Micro-array
PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
Changes in protein concentration of metabolic parameters due to the dietary intervention (VLCD-group)
Description
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
at baseline and after 5 weeks of VLCD diet
Title
Changes in protein concentration of metabolic parameters during weight-stable period (VLCD-group)
Description
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
after 5 weeks of VLCD diet and at 9 weeks
Title
change in protein concentration of metabolic parameters during follow-up (VLCD-group)
Description
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
at 9 weeks and after follow-up at 46 weeks
Title
change in protein concentration of metabolic parameters due to dietary intervention (LCD-group)
Description
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
at baseline and after 12 weeks of LCD diet
Title
change in protein concentration of metabolic parameters during weight-stable period (LCD-group)
Description
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
after 12 weeks of LCD diet and at 16 weeks
Title
change in protein concentration of metabolic parameters during follow-up (LCD-group)
Description
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
at 16 weeks and after follow-up at 53 weeks
Title
change in protein concentration of metabolic parameters in the LCD-group compared to the VLCD-group
Description
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Title
change in protein concentration of metabolic parameters in relation to weight regain during follow-up
Description
In LCD-group and VLCD-group
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Time Frame
at baseline, at 5, 9, 12, 16, 46 and 53 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age (years): 20-65
Body Mass Index (kg/m2): 28-35
Non-smokers
Exclusion Criteria:
Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1)
marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female)
planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator;
blood donation within the past 2 months prior to the study
weight change of >3 kg within 2 months prior to the study
psychiatric disease (based on medical history only)
pregnant or lactating women, or women planning to become pregnant within the next 12 months
surgically treated obesity
participation in other clinical studies within the last 3 months
drug abuse (based on clinical judgment)
unable to give informed consent
unable to engage in a low-calorie diet
unable to lose more then 8% of body weight after weight-loss period
following a special diet (vegetarian, Atkins or other).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marleen van Baak, Professor
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
35366329
Citation
Qiao Q, Bouwman FG, van Baak MA, Roumans NJT, Vink RG, Mariman ECM. Plasma Levels of Triglycerides and IL-6 Are Associated With Weight Regain and Fat Mass Expansion. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1920-1929. doi: 10.1210/clinem/dgac198.
Results Reference
derived
PubMed Identifier
32015415
Citation
Tareen SHK, Kutmon M, de Kok TM, Mariman ECM, van Baak MA, Evelo CT, Adriaens ME, Arts ICW. Stratifying cellular metabolism during weight loss: an interplay of metabolism, metabolic flexibility and inflammation. Sci Rep. 2020 Feb 3;10(1):1651. doi: 10.1038/s41598-020-58358-z.
Results Reference
derived
PubMed Identifier
29399976
Citation
Roumans NJT, Wang P, Vink RG, van Baak MA, Mariman ECM. Combined Analysis of Stress- and ECM-Related Genes in Their Effect on Weight Regain. Obesity (Silver Spring). 2018 Mar;26(3):492-498. doi: 10.1002/oby.22093. Epub 2018 Feb 5.
Results Reference
derived
PubMed Identifier
28639346
Citation
Vink RG, Roumans NJ, van der Kolk BW, Fazelzadeh P, Boekschoten MV, Mariman EC, van Baak MA. Adipose Tissue Meal-Derived Fatty Acid Uptake Before and After Diet-Induced Weight Loss in Adults with Overweight and Obesity. Obesity (Silver Spring). 2017 Aug;25(8):1391-1399. doi: 10.1002/oby.21903. Epub 2017 Jun 22.
Results Reference
derived
PubMed Identifier
28298393
Citation
Roumans NJ, Vink RG, Fazelzadeh P, van Baak MA, Mariman EC. A role for leukocyte integrins and extracellular matrix remodeling of adipose tissue in the risk of weight regain after weight loss. Am J Clin Nutr. 2017 May;105(5):1054-1062. doi: 10.3945/ajcn.116.148874. Epub 2017 Mar 15.
Results Reference
derived
PubMed Identifier
28179648
Citation
Vink RG, Roumans NJ, Cajlakovic M, Cleutjens JPM, Boekschoten MV, Fazelzadeh P, Vogel MAA, Blaak EE, Mariman EC, van Baak MA, Goossens GH. Diet-induced weight loss decreases adipose tissue oxygen tension with parallel changes in adipose tissue phenotype and insulin sensitivity in overweight humans. Int J Obes (Lond). 2017 May;41(5):722-728. doi: 10.1038/ijo.2017.38. Epub 2017 Feb 9.
Results Reference
derived
Learn more about this trial
An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect
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