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The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health (MERITS)

Primary Purpose

Abdominal Obesity, Metabolic Syndrome, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Whey protein powder
Maltodextrin powder
High fiber bread
Low fiber bread
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Obesity focused on measuring Whey protein, Dietary fibers, Wheat bran, Arabinoxylan, Postprandial lipaemia, Body composition, Blood pressure, Metabolic rate, Insulin sensitivity, Metabolic syndrome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Waist circumference ≥ 80 cm (women)/94 cm (men)
  • Age ≥40 years

Exclusion Criteria:

  • Significant cardiovascular, renal or endocrine disease
  • History of diabetes
  • ≥ 3 kg of weight gain or loss within the last 3 months
  • Any change in medication within the last month
  • Treatment with steroids
  • Pregnancy, breastfeeding or planned pregnancy
  • Psychiatric history
  • Alcohol or drug addiction
  • Dietary fiber supplement within the last month

Sites / Locations

  • Aarhus University Hospital, Dep. of clinical nutrition research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

HP/HF

HP/LF

LP/HF

LP/LF

Arm Description

Whey protein powder / High fiber bread

Whey protein powder / Low fiber bread

Maltodextrin powder / High fiber bread

Maltodextrin powder / Low fiber bread

Outcomes

Primary Outcome Measures

Postprandial triglyceride response
Postprandial triglyceride response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.

Secondary Outcome Measures

24 hours blood pressure (BP)
Arteriograph 24, TensioMed, Hungary
24 hours augmentation Index (AI)
Arteriograph 24, TensioMed, Hungary
Respiratory Exchange Ratio
Measured twice during each meal test by indirect calorimetry (hood)
Body composition
Dual Energy X-ray Absorptiometry (DEXA) scan: Total body fat percentage, lean mass percentage, gynoid and android fat percentage
Postprandial apolipoprotein B48 response
Postprandial apolipoprotein response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Glucose response during high-fat meal test
Glucose response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Insulin response during high-fat meal test
Insulin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Glucagon response during high-fat meal test
Glukagon response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Glucagon-like peptide 1 (GLP-1) response during high-fat meal test
GLP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Glucagon-like peptide 2 (GLP-2) response during high-fat meal test
GLP-2 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Glucose-dependent insulinotropic polypeptide (GIP) response during high-fat meal test
GIP response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Ghrelin response during high-fat meal test
Ghrelin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Peptide tyrosine tyrosine (PYY) response during high-fat meal test
PYY response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Adiponectin response during high-fat meal test
Adiponectin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)
Non-esterified fatty acids (NEFA) response during high-fat meal test
NEFA response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)
Interleukin-6 (IL-6) response during high-fat meal test
IL-6 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Monocyte chemoattractant protein 1 (MCP-1) response during high-fat meal test
MCP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from 0 - 240 min)
RANTES (CCL5) response during high-fat meal test
CCL5 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
High-sensitive c-reactive protein (hs-CRP) response during high-fat meal test
hs-CRP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Procollagen type 1 N-terminal propeptide (P1NP) response during high-fat meal test
P1NP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
C-telopeptide (CTX) response during high-fat meal test
CTX response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Parathyroid hormone (PTH) response during high-fat meal test
PTH response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Osteoprotegrin response during high-fat meal test
Osteoprotegrin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Osteocalcin response during high-fat meal test
Osteocalcin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
25-dihydroxy vitamin D
Fasting value measured at baseline and week 12
Phosphate
Fasting value measured at baseline and week 12
Magnesium
Fasting value measured at baseline and week 12
Total cholesterol
Fasting value measured at baseline and week 12
Low density lipoprotein (LDL)
Fasting value measured at baseline and week 12
High density lipoprotein (HDL)
Fasting value measured at baseline and week 12
Glucose response during oral glucose tolerance test (OGTT)
Glucose measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Insulin response during oral glucose tolerance test (OGTT)
Insulin measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Glucagon response during oral glucose tolerance test (OGTT)
Glucagon measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Glucagon-like peptide 1 (GLP-1) response during oral glucose tolerance test (OGTT)
GLP-1 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Glucagon-like peptide 2 (GLP-2) response during oral glucose tolerance test (OGTT)
GLP-2 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Glucose-dependent insulinotropic polypeptide (GIP) response during oral glucose tolerance test (OGTT)
GIP measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Parathyroid hormone (PTH) response during oral glucose tolerance test (OGTT)
PTH measured as incremental Area Under the Curve (iAUC from 0-90 min)
C-telopeptide (CTX) response during oral glucose tolerance test (OGTT)
CTX measured as incremental Area Under the Curve (iAUC from 0-90 min)
Procollagen type 1 N-terminal propeptide (P1NP) response during oral glucose tolerance test (OGTT)
P1NP measured as incremental Area Under the Curve (iAUC from 0-90 min)
Osteoprotegrin response during oral glucose tolerance test (OGTT)
Osteoprotegrin measured as incremental Area Under the Curve (iAUC from 0-90 min)
Osteocalcin response during oral glucose tolerance test (OGTT)
Osteocalcin measured as incremental Area Under the Curve (iAUC from 0-90 min)
Waist and hip circumference.
Waist and hip circumference in cm
Body weight
Body weight in kg
Body Mass Index
kg/m2
Adipose tissue gene expression
Subcutaneous fat tissue biopsy performed at baseline and week 12 for the measurement of changes in genes related to lipid and glucose metabolism and insulin signalling.
Adipose tissue proliferation and differentiation
Subcutaneous fat tissue biopsy performed at baseline and week 12 for measuring proliferation and differentiation processes of preadipocyte stem cells into mature adipocytes, and to test the effect of diets on expanding the capacity of the subcutaneous adipose tissue to store fat.
Urinary calcium
Urinary calcium excretion measured in 24-hour urine samples collected at baseline and week 12
Urinary nitrogen
Urinary nitrogen excretion measured in 24-hour urine samples collected at baseline and week 12
Metabolomics, plasma
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Metabolomics, urine
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Metabolomics, faeces
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Insulin sensitivity during oral glucose tolerance test (OGTT)
Homeostasis model assessment - insulin resistance (HOMA-IR) and Matsuda Index calculated based on blood glucose and insulin measurements during OGTT
Appetite assessment during high-fat meal test
Visual Analog Scale (VAS) electronic questionnaire
Microbiota
Non-targeted microbiome and metabolome analyses using high-throughput DNA sequencing on Illumina Miseq and Liquid Chromatography - Mass Spectrometry (LC-MS) metabolomics,

Full Information

First Posted
August 19, 2016
Last Updated
July 13, 2017
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, Rigshospitalet, Denmark, University of California, Davis, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02931630
Brief Title
The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
Acronym
MERITS
Official Title
The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, Rigshospitalet, Denmark, University of California, Davis, University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The prevalence of overweight and lifestyle related diseases such as cardiovascular disease (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D. Dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies. Whey protein is furthermore seen to show positive effects on bone turnover. The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein (separately or combined) over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects. A total of 80 people with abdominal obesity will be included. The design is a randomized, double blinded, controlled dietary intervention trial. Subjects are assigned to one of four experimental groups. Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet. The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability. The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing CVD. PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured. The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL.
Detailed Description
Please refer to summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Metabolic Syndrome, Type 2 Diabetes, Cardiovascular Disease
Keywords
Whey protein, Dietary fibers, Wheat bran, Arabinoxylan, Postprandial lipaemia, Body composition, Blood pressure, Metabolic rate, Insulin sensitivity, Metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HP/HF
Arm Type
Experimental
Arm Description
Whey protein powder / High fiber bread
Arm Title
HP/LF
Arm Type
Experimental
Arm Description
Whey protein powder / Low fiber bread
Arm Title
LP/HF
Arm Type
Experimental
Arm Description
Maltodextrin powder / High fiber bread
Arm Title
LP/LF
Arm Type
Experimental
Arm Description
Maltodextrin powder / Low fiber bread
Intervention Type
Other
Intervention Name(s)
Whey protein powder
Intervention Description
60 g of whey protein powder
Intervention Type
Other
Intervention Name(s)
Maltodextrin powder
Intervention Description
60 g of Maltodextrin powder
Intervention Type
Other
Intervention Name(s)
High fiber bread
Intervention Description
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
Intervention Type
Other
Intervention Name(s)
Low fiber bread
Intervention Description
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
Primary Outcome Measure Information:
Title
Postprandial triglyceride response
Description
Postprandial triglyceride response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time Frame
Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.
Secondary Outcome Measure Information:
Title
24 hours blood pressure (BP)
Description
Arteriograph 24, TensioMed, Hungary
Time Frame
Performed at baseline and week 12
Title
24 hours augmentation Index (AI)
Description
Arteriograph 24, TensioMed, Hungary
Time Frame
Performed at baseline and week 12
Title
Respiratory Exchange Ratio
Description
Measured twice during each meal test by indirect calorimetry (hood)
Time Frame
Meal test: -30 and 140 min. Performed at baseline and week 12.
Title
Body composition
Description
Dual Energy X-ray Absorptiometry (DEXA) scan: Total body fat percentage, lean mass percentage, gynoid and android fat percentage
Time Frame
Performed at baseline and week 12
Title
Postprandial apolipoprotein B48 response
Description
Postprandial apolipoprotein response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time Frame
Meal test: -15, 0, 60, 240, 360 min. Performed at baseline and at 12 weeks.
Title
Glucose response during high-fat meal test
Description
Glucose response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Insulin response during high-fat meal test
Description
Insulin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Glucagon response during high-fat meal test
Description
Glukagon response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Glucagon-like peptide 1 (GLP-1) response during high-fat meal test
Description
GLP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Glucagon-like peptide 2 (GLP-2) response during high-fat meal test
Description
GLP-2 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Glucose-dependent insulinotropic polypeptide (GIP) response during high-fat meal test
Description
GIP response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Ghrelin response during high-fat meal test
Description
Ghrelin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Peptide tyrosine tyrosine (PYY) response during high-fat meal test
Description
PYY response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time Frame
Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Adiponectin response during high-fat meal test
Description
Adiponectin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)
Time Frame
Meal test: -15, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Non-esterified fatty acids (NEFA) response during high-fat meal test
Description
NEFA response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)
Time Frame
Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Title
Interleukin-6 (IL-6) response during high-fat meal test
Description
IL-6 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Title
Monocyte chemoattractant protein 1 (MCP-1) response during high-fat meal test
Description
MCP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from 0 - 240 min)
Time Frame
Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Title
RANTES (CCL5) response during high-fat meal test
Description
CCL5 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Title
High-sensitive c-reactive protein (hs-CRP) response during high-fat meal test
Description
hs-CRP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Title
Procollagen type 1 N-terminal propeptide (P1NP) response during high-fat meal test
Description
P1NP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Title
C-telopeptide (CTX) response during high-fat meal test
Description
CTX response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Title
Parathyroid hormone (PTH) response during high-fat meal test
Description
PTH response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Title
Osteoprotegrin response during high-fat meal test
Description
Osteoprotegrin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Title
Osteocalcin response during high-fat meal test
Description
Osteocalcin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time Frame
Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Title
25-dihydroxy vitamin D
Description
Fasting value measured at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
Phosphate
Description
Fasting value measured at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
Magnesium
Description
Fasting value measured at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
Total cholesterol
Description
Fasting value measured at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
Low density lipoprotein (LDL)
Description
Fasting value measured at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
High density lipoprotein (HDL)
Description
Fasting value measured at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
Glucose response during oral glucose tolerance test (OGTT)
Description
Glucose measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time Frame
OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Title
Insulin response during oral glucose tolerance test (OGTT)
Description
Insulin measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time Frame
OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Title
Glucagon response during oral glucose tolerance test (OGTT)
Description
Glucagon measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time Frame
OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Title
Glucagon-like peptide 1 (GLP-1) response during oral glucose tolerance test (OGTT)
Description
GLP-1 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time Frame
OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Title
Glucagon-like peptide 2 (GLP-2) response during oral glucose tolerance test (OGTT)
Description
GLP-2 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time Frame
OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Title
Glucose-dependent insulinotropic polypeptide (GIP) response during oral glucose tolerance test (OGTT)
Description
GIP measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time Frame
OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Title
Parathyroid hormone (PTH) response during oral glucose tolerance test (OGTT)
Description
PTH measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time Frame
OGTT: 0, 30, 90 min. Performed at baseline and week 12
Title
C-telopeptide (CTX) response during oral glucose tolerance test (OGTT)
Description
CTX measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time Frame
OGTT: 0, 30, 90 min. Performed at baseline and week 12
Title
Procollagen type 1 N-terminal propeptide (P1NP) response during oral glucose tolerance test (OGTT)
Description
P1NP measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time Frame
OGTT: 0, 30, 90 min. Performed at baseline and week 12
Title
Osteoprotegrin response during oral glucose tolerance test (OGTT)
Description
Osteoprotegrin measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time Frame
OGTT: 0, 30, 90 min. Performed at baseline and week 12
Title
Osteocalcin response during oral glucose tolerance test (OGTT)
Description
Osteocalcin measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time Frame
OGTT: 0, 30, 90 min. Performed at baseline and week 12
Title
Waist and hip circumference.
Description
Waist and hip circumference in cm
Time Frame
Change from week 0 to week 12
Title
Body weight
Description
Body weight in kg
Time Frame
Change from week 0 to week 12
Title
Body Mass Index
Description
kg/m2
Time Frame
Change from week 0 to week 12
Title
Adipose tissue gene expression
Description
Subcutaneous fat tissue biopsy performed at baseline and week 12 for the measurement of changes in genes related to lipid and glucose metabolism and insulin signalling.
Time Frame
Change from week 0 to week 12
Title
Adipose tissue proliferation and differentiation
Description
Subcutaneous fat tissue biopsy performed at baseline and week 12 for measuring proliferation and differentiation processes of preadipocyte stem cells into mature adipocytes, and to test the effect of diets on expanding the capacity of the subcutaneous adipose tissue to store fat.
Time Frame
Change from week 0 to week 12
Title
Urinary calcium
Description
Urinary calcium excretion measured in 24-hour urine samples collected at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
Urinary nitrogen
Description
Urinary nitrogen excretion measured in 24-hour urine samples collected at baseline and week 12
Time Frame
Change from week 0 to week 12
Title
Metabolomics, plasma
Description
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Time Frame
OGTT: -15, 30, 60, 90, 120 min. Performed at baseline and week 12.
Title
Metabolomics, urine
Description
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Time Frame
24-hour urine collection performed at baseline and week 12.
Title
Metabolomics, faeces
Description
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Time Frame
Collected at baseline and week 12.
Title
Insulin sensitivity during oral glucose tolerance test (OGTT)
Description
Homeostasis model assessment - insulin resistance (HOMA-IR) and Matsuda Index calculated based on blood glucose and insulin measurements during OGTT
Time Frame
OGTT performed at baseline and week 12 (blood sampling at -15, -10, 0, 30, 60, 90, 120 min)
Title
Appetite assessment during high-fat meal test
Description
Visual Analog Scale (VAS) electronic questionnaire
Time Frame
Meal test: Questionnaire at -10, 0, 30, 60, 90, 120, 180, 240, 300, 360 min. Performed at baseline and week 12.
Title
Microbiota
Description
Non-targeted microbiome and metabolome analyses using high-throughput DNA sequencing on Illumina Miseq and Liquid Chromatography - Mass Spectrometry (LC-MS) metabolomics,
Time Frame
Faecal samples collected at baseline and week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Waist circumference ≥ 80 cm (women)/94 cm (men) Age ≥40 years Exclusion Criteria: Significant cardiovascular, renal or endocrine disease History of diabetes ≥ 3 kg of weight gain or loss within the last 3 months Any change in medication within the last month Treatment with steroids Pregnancy, breastfeeding or planned pregnancy Psychiatric history Alcohol or drug addiction Dietary fiber supplement within the last month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Gregersen, MD, ph.d.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Knud Erik B. Knudsen, Professor
Organizational Affiliation
Department of Animal Science, University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital, Dep. of clinical nutrition research
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35422766
Citation
Fuglsang-Nielsen R, Rakvaag E, Vestergaard P, Hermansen K, Gregersen S, Starup-Linde J. The Effects of 12-Weeks Whey Protein Supplements on Markers of Bone Turnover in Adults With Abdominal Obesity - A Post Hoc Analysis. Front Endocrinol (Lausanne). 2022 Mar 29;13:832897. doi: 10.3389/fendo.2022.832897. eCollection 2022.
Results Reference
derived

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The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health

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