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

July 28, 2022 updated by: University of the Balearic Islands

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Islands
      • Palma De Mallorca, Balearic Islands, Spain, 07122
        • University of the Balearic Islands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normal-weight (NW)
Individuals with BMI<25 kg/m2
Experimental: Overweight-Obese (OW-OB)
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

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.
Experimental: Metabolically obese normal-weight (MONW)
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

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.

What is the study measuring?

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
Time Frame: Baseline point (all groups)
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
Time Frame: 3 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
3 months (OW-OB and MONW groups)
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
Time Frame: 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
6 months (OW-OB and MONW groups)
Weight
Time Frame: Baseline point (all groups)
Weight (kg)
Baseline point (all groups)
Weight
Time Frame: 3 months (OW-OB and MONW groups)
Weight (kg)
3 months (OW-OB and MONW groups)
Weight
Time Frame: 6 months (OW-OB and MONW groups)
Weight (kg)
6 months (OW-OB and MONW groups)
Body Mass Index (BMI)
Time Frame: Baseline point (all groups)
Weight and height will be combined to report BMI in kg/m^2).
Baseline point (all groups)
Body Mass Index (BMI)
Time Frame: 3 months (OW-OB and MONW groups)
Weight and height will be combined to report BMI in kg/m^2).
3 months (OW-OB and MONW groups)
Body Mass Index (BMI)
Time Frame: 6 months (OW-OB and MONW groups)
Weight and height will be combined to report BMI in kg/m^2).
6 months (OW-OB and MONW groups)
Body composition
Time Frame: Baseline point (all groups)
Body composition (fat mass in kg) measured using a DXA scanner
Baseline point (all groups)
Body composition
Time Frame: 3 months (OW-OB and MONW groups)
Body composition (fat mass in kg) measured using a DXA scanner
3 months (OW-OB and MONW groups)
Body composition
Time Frame: 6 months (OW-OB and MONW groups)
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)
Time Frame: Baseline point (all groups)
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)
Time Frame: 3 months (OW-OB and MONW groups)
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)
Time Frame: 6 months (OW-OB and MONW groups)
Circulating parameters measured in mg/dL
6 months (OW-OB and MONW groups)
Circulating gamma-glutamyl transpeptidase (GGT)
Time Frame: Baseline point (all groups)
GGT measured in U/L
Baseline point (all groups)
Circulating gamma-glutamyl transpeptidase (GGT)
Time Frame: 3 months (OW-OB and MONW groups)
GGT measured in U/L
3 months (OW-OB and MONW groups)
Circulating gamma-glutamyl transpeptidase (GGT)
Time Frame: 6 months (OW-OB and MONW groups)
GGT measured in U/L
6 months (OW-OB and MONW groups)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Balearic Islands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nºIB 3216/16 PI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be shared in due time if considered relevant for other research. With our current objectives, it is not considered necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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