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Analysis of Metabolic State in Normal-weight and Overweight-obese After Lifestyle Improvement and/or Weight Loss (METAHEALTH)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dietary and physical activity intervention
Sponsored by
University of the Balearic Islands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Overweight, Obesity, Blood cells, Metabolic health, Weight loss

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18-45 years
  • Participants with no chronic disease (excluding those related to overweight/obesity)

Exclusion Criteria:

  • Minors or older than 45 years
  • Presence of a metabolic illness
  • Intake of regular medication or drugs
  • Precedents of alcohol or drug consumption
  • Physic of psychic disability

Sites / Locations

  • University of the Balearic Islands

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Normal-weight (NW)

Overweight-Obese (OW-OB)

Metabolically obese normal-weight (MONW)

Arm Description

Individuals with BMI<25 kg/m2

Individuals with BMI>25 kg/m2, submitted to a nutritional intervention (hypocaloric balanced diet) during 6 months and prescription of physical activity to achieve weigh loss

Individuals with BMI<25 kg/m2, with metabolic alterations related to obesity (hypertriglyceridemia, hypercholesterolemia, hyperglycaemia, hypertension or high waist-hip ratio), submitted to an intervention to improve dietary habits and physical activity in order to achieve a better body composition and metabolic health. Mediterranean diet will be and aerobic and strength exercises will be advised to these individuals.

Outcomes

Primary Outcome Measures

Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
Weight
Weight (kg)
Weight
Weight (kg)
Weight
Weight (kg)
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2).
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2).
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2).
Body composition
Body composition (fat mass in kg) measured using a DXA scanner
Body composition
Body composition (fat mass in kg) measured using a DXA scanner
Body composition
Body composition (fat mass in kg) measured using a DXA scanner
Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
Circulating parameters measured in mg/dL
Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
Circulating parameters measured in mg/dL
Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
Circulating parameters measured in mg/dL
Circulating gamma-glutamyl transpeptidase (GGT)
GGT measured in U/L
Circulating gamma-glutamyl transpeptidase (GGT)
GGT measured in U/L
Circulating gamma-glutamyl transpeptidase (GGT)
GGT measured in U/L

Secondary Outcome Measures

Height
Height (m)
Height
Height (m)
Height
Height (m)
Waist-hip ratio
Waist-hip ratio
Waist-hip ratio
Waist-hip ratio
Waist-hip ratio
Waist-hip ratio
Blood pressure
Blood pressure (mm Hg)
Blood pressure
Blood pressure (mm Hg)
Blood pressure
Blood pressure (mm Hg)

Full Information

First Posted
May 13, 2020
Last Updated
July 28, 2022
Sponsor
University of the Balearic Islands
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1. Study Identification

Unique Protocol Identification Number
NCT04402697
Brief Title
Analysis of Metabolic State in Normal-weight and Overweight-obese After Lifestyle Improvement and/or Weight Loss
Acronym
METAHEALTH
Official Title
Study of the Usefulness of Blood Cells for the Analysis of Metabolic Recovery After Weight Loss (METAHEALTH-TEST)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Balearic Islands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to design and validate a test, METAHEALTH-TEST, based in gene expression analysis in blood cells, to quickly and easily analyse metabolic health. This test will be used to analyse metabolic improvement in overweight/obese individuals and in metabolically obese normal-weight (MONW) individuals after undergoing a weight loss intervention and/or an intervention for improvement in eating habits and lifestyle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, Blood cells, Metabolic health, Weight loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Volunteers are assigned to three groups for the duration of the study: Normal-weight Overweight-Obese Metabolically obese normal-weight
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal-weight (NW)
Arm Type
No Intervention
Arm Description
Individuals with BMI<25 kg/m2
Arm Title
Overweight-Obese (OW-OB)
Arm Type
Experimental
Arm Description
Individuals with BMI>25 kg/m2, submitted to a nutritional intervention (hypocaloric balanced diet) during 6 months and prescription of physical activity to achieve weigh loss
Arm Title
Metabolically obese normal-weight (MONW)
Arm Type
Experimental
Arm Description
Individuals with BMI<25 kg/m2, with metabolic alterations related to obesity (hypertriglyceridemia, hypercholesterolemia, hyperglycaemia, hypertension or high waist-hip ratio), submitted to an intervention to improve dietary habits and physical activity in order to achieve a better body composition and metabolic health. Mediterranean diet will be and aerobic and strength exercises will be advised to these individuals.
Intervention Type
Other
Intervention Name(s)
Dietary and physical activity intervention
Intervention Description
OW-OB group: 6-month program of weight loss consisting in a low-calorie food plan (30% reduction in the individual energy requirements) with dietary sessions and exercise counselling. MONW group: 6-month program to improve eating habits (Mediterranean diet) with dietary sessions and exercise counselling.
Primary Outcome Measure Information:
Title
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
Description
The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
Time Frame
Baseline point (all groups)
Title
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
Description
The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
Time Frame
3 months (OW-OB and MONW groups)
Title
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
Description
The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
Time Frame
6 months (OW-OB and MONW groups)
Title
Weight
Description
Weight (kg)
Time Frame
Baseline point (all groups)
Title
Weight
Description
Weight (kg)
Time Frame
3 months (OW-OB and MONW groups)
Title
Weight
Description
Weight (kg)
Time Frame
6 months (OW-OB and MONW groups)
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2).
Time Frame
Baseline point (all groups)
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2).
Time Frame
3 months (OW-OB and MONW groups)
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2).
Time Frame
6 months (OW-OB and MONW groups)
Title
Body composition
Description
Body composition (fat mass in kg) measured using a DXA scanner
Time Frame
Baseline point (all groups)
Title
Body composition
Description
Body composition (fat mass in kg) measured using a DXA scanner
Time Frame
3 months (OW-OB and MONW groups)
Title
Body composition
Description
Body composition (fat mass in kg) measured using a DXA scanner
Time Frame
6 months (OW-OB and MONW groups)
Title
Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
Description
Circulating parameters measured in mg/dL
Time Frame
Baseline point (all groups)
Title
Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
Description
Circulating parameters measured in mg/dL
Time Frame
3 months (OW-OB and MONW groups)
Title
Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
Description
Circulating parameters measured in mg/dL
Time Frame
6 months (OW-OB and MONW groups)
Title
Circulating gamma-glutamyl transpeptidase (GGT)
Description
GGT measured in U/L
Time Frame
Baseline point (all groups)
Title
Circulating gamma-glutamyl transpeptidase (GGT)
Description
GGT measured in U/L
Time Frame
3 months (OW-OB and MONW groups)
Title
Circulating gamma-glutamyl transpeptidase (GGT)
Description
GGT measured in U/L
Time Frame
6 months (OW-OB and MONW groups)
Secondary Outcome Measure Information:
Title
Height
Description
Height (m)
Time Frame
Baseline point (all groups)
Title
Height
Description
Height (m)
Time Frame
3 months (OW-OB and MONW groups)
Title
Height
Description
Height (m)
Time Frame
6 months (OW-OB and MONW groups)
Title
Waist-hip ratio
Description
Waist-hip ratio
Time Frame
Baseline point (all groups)
Title
Waist-hip ratio
Description
Waist-hip ratio
Time Frame
3 months (OW-OB and MONW groups)
Title
Waist-hip ratio
Description
Waist-hip ratio
Time Frame
6 months (OW-OB and MONW groups)
Title
Blood pressure
Description
Blood pressure (mm Hg)
Time Frame
Baseline point (all groups)
Title
Blood pressure
Description
Blood pressure (mm Hg)
Time Frame
3 months (OW-OB and MONW groups)
Title
Blood pressure
Description
Blood pressure (mm Hg)
Time Frame
6 months (OW-OB and MONW groups)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18-45 years Participants with no chronic disease (excluding those related to overweight/obesity) Exclusion Criteria: Minors or older than 45 years Presence of a metabolic illness Intake of regular medication or drugs Precedents of alcohol or drug consumption Physic of psychic disability
Facility Information:
Facility Name
University of the Balearic Islands
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07122
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be shared in due time if considered relevant for other research. With our current objectives, it is not considered necessary.
Citations:
PubMed Identifier
33978191
Citation
Costa A, Konieczna J, Reynes B, Martin M, Fiol M, Palou A, Romaguera D, Oliver P. CUN-BAE Index as a Screening Tool to Identify Increased Metabolic Risk in Apparently Healthy Normal-Weight Adults and Those with Obesity. J Nutr. 2021 Aug 7;151(8):2215-2225. doi: 10.1093/jn/nxab117.
Results Reference
derived

Learn more about this trial

Analysis of Metabolic State in Normal-weight and Overweight-obese After Lifestyle Improvement and/or Weight Loss

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