NCT04402697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

5.6 years

First QC Date

May 13, 2020

Last Update Submit

July 28, 2022

Conditions

Overweight and Obesity

Keywords

OverweightObesityBlood cellsMetabolic healthWeight loss

Outcome Measures

Primary Outcomes (18)

  • 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 Outcomes (9)

  • Height

    Baseline point (all groups)

  • Height

    3 months (OW-OB and MONW groups)

  • Height

    6 months (OW-OB and MONW groups)

  • Waist-hip ratio

    Baseline point (all groups)

  • Waist-hip ratio

    3 months (OW-OB and MONW groups)

  • +4 more secondary outcomes

Study Arms (3)

Normal-weight (NW)

NO INTERVENTION

Individuals with BMI\<25 kg/m2

Overweight-Obese (OW-OB)

EXPERIMENTAL

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

Metabolically obese normal-weight (MONW)

EXPERIMENTAL

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

Interventions

Dietary and physical activity interventionOTHER

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.

Metabolically obese normal-weight (MONW)Overweight-Obese (OW-OB)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-45 years
  • Participants with no chronic disease (excluding those related to overweight/obesity)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Related Publications (1)

  • Costa A, Konieczna J, Reynes B, Martin M, Fiol M, Palou A, Romaguera D, Oliver P. CUN-BAE Index as a Screening Tool to Identify Increased Metabolic Risk in Apparently Healthy Normal-Weight Adults and Those with Obesity. J Nutr. 2021 Aug 7;151(8):2215-2225. doi: 10.1093/jn/nxab117.

    PMID: 33978191DERIVED

MeSH Terms

Conditions

OverweightObesityWeight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Volunteers are assigned to three groups for the duration of the study: 1. Normal-weight 2. Overweight-Obese 3. Metabolically obese normal-weight
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 27, 2020

Study Start

May 25, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

ES(1)