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

Overweight and Obesity Clinical Trial

— METAHEALTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402697
• Other study ID #: nºIB 3216/16 PI
• Status: Completed
• Phase: N/A
• Start date: May 25, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: University of the Balearic Islands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Other:
• Dietary and physical activity intervention
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.

Locations

Country	Name	City	State
Spain	University of the Balearic Islands	Palma De Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
University of the Balearic Islands

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Weight	Weight (kg)	Baseline point (all groups)
Primary	Weight	Weight (kg)	3 months (OW-OB and MONW groups)
Primary	Weight	Weight (kg)	6 months (OW-OB and MONW groups)
Primary	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2).	Baseline point (all groups)
Primary	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2).	3 months (OW-OB and MONW groups)
Primary	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2).	6 months (OW-OB and MONW groups)
Primary	Body composition	Body composition (fat mass in kg) measured using a DXA scanner	Baseline point (all groups)
Primary	Body composition	Body composition (fat mass in kg) measured using a DXA scanner	3 months (OW-OB and MONW groups)
Primary	Body composition	Body composition (fat mass in kg) measured using a DXA scanner	6 months (OW-OB and MONW groups)
Primary	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)
Primary	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)
Primary	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)
Primary	Circulating gamma-glutamyl transpeptidase (GGT)	GGT measured in U/L	Baseline point (all groups)
Primary	Circulating gamma-glutamyl transpeptidase (GGT)	GGT measured in U/L	3 months (OW-OB and MONW groups)
Primary	Circulating gamma-glutamyl transpeptidase (GGT)	GGT measured in U/L	6 months (OW-OB and MONW groups)
Secondary	Height	Height (m)	Baseline point (all groups)
Secondary	Height	Height (m)	3 months (OW-OB and MONW groups)
Secondary	Height	Height (m)	6 months (OW-OB and MONW groups)
Secondary	Waist-hip ratio	Waist-hip ratio	Baseline point (all groups)
Secondary	Waist-hip ratio	Waist-hip ratio	3 months (OW-OB and MONW groups)
Secondary	Waist-hip ratio	Waist-hip ratio	6 months (OW-OB and MONW groups)
Secondary	Blood pressure	Blood pressure (mm Hg)	Baseline point (all groups)
Secondary	Blood pressure	Blood pressure (mm Hg)	3 months (OW-OB and MONW groups)
Secondary	Blood pressure	Blood pressure (mm Hg)	6 months (OW-OB and MONW groups)

External Links

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