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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: Dietary and physical activity intervention

• Registration Number: NCT04402697
• Lead Sponsor: University of the Balearic Islands

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-25
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-27
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Overweight-Obese (OW-OB)	Dietary and physical activity intervention	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
Metabolically obese normal-weight (MONW)	Dietary and physical activity intervention	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.

Primary Outcome Measures

Name	Time	Method
Body composition	6 months (OW-OB and MONW groups)	Body composition (fat mass in kg) measured using a DXA scanner
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells	6 months (OW-OB and MONW groups)	The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
Weight	6 months (OW-OB and MONW groups)	Weight (kg)
Body Mass Index (BMI)	6 months (OW-OB and MONW groups)	Weight and height will be combined to report BMI in kg/m\^2).
Circulating gamma-glutamyl transpeptidase (GGT)	6 months (OW-OB and MONW groups)	GGT measured in U/L
Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)	6 months (OW-OB and MONW groups)	Circulating parameters measured in mg/dL

Secondary Outcome Measures

Name	Time	Method
Waist-hip ratio	6 months (OW-OB and MONW groups)	Waist-hip ratio
Blood pressure	6 months (OW-OB and MONW groups)	Blood pressure (mm Hg)
Height	6 months (OW-OB and MONW groups)	Height (m)

Trial Locations

Locations (1)

University of the Balearic Islands; 🇪🇸 Palma De Mallorca, Balearic Islands, Spain