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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04402697
Acronym
METAHEALTH
Enrollment
80
Registered
2020-05-27
Start date
2016-05-25
Completion date
2021-12-31
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Overweight, Obesity, Blood cells, Metabolic health, Weight loss

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.

Interventions

OTHERDietary 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.

Sponsors

University of the Balearic Islands
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Volunteers are assigned to three groups for the duration of the study: 1. Normal-weight 2. Overweight-Obese 3. Metabolically obese normal-weight

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of individuals responding to fasting assessed by changes in gene expression profile of blood cellsBaseline point (all groups)The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
WeightBaseline point (all groups)Weight (kg)
Body Mass Index (BMI)Baseline point (all groups)Weight and height will be combined to report BMI in kg/m\^2).
Body compositionBaseline point (all groups)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)Baseline point (all groups)Circulating parameters measured in mg/dL
Circulating gamma-glutamyl transpeptidase (GGT)Baseline point (all groups)GGT measured in U/L

Secondary

MeasureTime frameDescription
HeightBaseline point (all groups)Height (m)
Waist-hip ratioBaseline point (all groups)Waist-hip ratio
Blood pressureBaseline point (all groups)Blood pressure (mm Hg)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026