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

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Usefulness of Blood Cells for the Analysis of Metabolic Recovery After Weight Loss (METAHEALTH-TEST)

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Dietary and physical activity intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal-weight (NW)<br>Individuals with BMI<25 kg/m2 | |
| Experimental: Overweight-Obese (OW-OB)<br>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 | Other: Dietary and physical activity intervention<br>* 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.<br>|
| Experimental: Metabolically obese normal-weight (MONW)<br>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. | Other: Dietary and physical activity intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline point (all groups) | 
| 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 | 3 months (OW-OB and MONW groups) | 
| 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 | 6 months (OW-OB and MONW groups) | 
| Weight | Weight (kg) | Baseline point (all groups) | 
| Weight | Weight (kg) | 3 months (OW-OB and MONW groups) | 
| Weight | Weight (kg) | 6 months (OW-OB and MONW groups) | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2). | Baseline point (all groups) | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2). | 3 months (OW-OB and MONW groups) | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2). | 6 months (OW-OB and MONW groups) | 
| Body composition | Body composition (fat mass in kg) measured using a DXA scanner | Baseline point (all groups) | 
| Body composition | Body composition (fat mass in kg) measured using a DXA scanner | 3 months (OW-OB and MONW groups) | 
| Body composition | Body composition (fat mass in kg) measured using a DXA scanner | 6 months (OW-OB and MONW groups) | 
| 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 | Baseline point (all groups) | 
| 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 | 3 months (OW-OB and MONW groups) | 
| 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 | 6 months (OW-OB and MONW groups) | 
| Circulating gamma-glutamyl transpeptidase (GGT) | GGT measured in U/L | Baseline point (all groups) | 
| Circulating gamma-glutamyl transpeptidase (GGT) | GGT measured in U/L | 3 months (OW-OB and MONW groups) | 
| Circulating gamma-glutamyl transpeptidase (GGT) | GGT measured in U/L | 6 months (OW-OB and MONW groups) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Height (m) | Baseline point (all groups) | 
| Height | Height (m) | 3 months (OW-OB and MONW groups) | 
| Height | Height (m) | 6 months (OW-OB and MONW groups) | 
| Waist-hip ratio | Waist-hip ratio | Baseline point (all groups) | 
| Waist-hip ratio | Waist-hip ratio | 3 months (OW-OB and MONW groups) | 
| Waist-hip ratio | Waist-hip ratio | 6 months (OW-OB and MONW groups) | 
| Blood pressure | Blood pressure (mm Hg) | Baseline point (all groups) | 
| Blood pressure | Blood pressure (mm Hg) | 3 months (OW-OB and MONW groups) | 
| Blood pressure | Blood pressure (mm Hg) | 6 months (OW-OB and MONW groups) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Blood cells, Metabolic health, Weight loss