Clinical trial NCT04402697: Analysis of Metabolic State in Normal-weight and Overweight-obese After Lifestyle Improvement and/or Weight Loss
Official title: Study of the Usefulness of Blood Cells for the Analysis of Metabolic Recovery After Weight Loss (METAHEALTH-TEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Blood cells
Metabolic health
Weight loss
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
timeFrame: Baseline point (all groups)
measure: Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
timeFrame: 3 months (OW-OB and MONW groups)
measure: Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
timeFrame: 6 months (OW-OB and MONW groups)
measure: Weight
timeFrame: Baseline point (all groups)
measure: Weight
timeFrame: 3 months (OW-OB and MONW groups)
measure: Weight
timeFrame: 6 months (OW-OB and MONW groups)
measure: Body Mass Index (BMI)
timeFrame: Baseline point (all groups)
measure: Body Mass Index (BMI)
timeFrame: 3 months (OW-OB and MONW groups)
measure: Body Mass Index (BMI)
timeFrame: 6 months (OW-OB and MONW groups)
measure: Body composition
timeFrame: Baseline point (all groups)
measure: Body composition
timeFrame: 3 months (OW-OB and MONW groups)
measure: Body composition
timeFrame: 6 months (OW-OB and MONW groups)
measure: Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
timeFrame: Baseline point (all groups)
measure: Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
timeFrame: 3 months (OW-OB and MONW groups)
measure: Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
timeFrame: 6 months (OW-OB and MONW groups)
measure: Circulating gamma-glutamyl transpeptidase (GGT)
timeFrame: Baseline point (all groups)
measure: Circulating gamma-glutamyl transpeptidase (GGT)
timeFrame: 3 months (OW-OB and MONW groups)
measure: Circulating gamma-glutamyl transpeptidase (GGT)
timeFrame: 6 months (OW-OB and MONW groups)
Secondary outcomes:
measure: Height
timeFrame: Baseline point (all groups)
measure: Height
timeFrame: 3 months (OW-OB and MONW groups)
measure: Height
timeFrame: 6 months (OW-OB and MONW groups)
measure: Waist-hip ratio
timeFrame: Baseline point (all groups)
measure: Waist-hip ratio
timeFrame: 3 months (OW-OB and MONW groups)
measure: Waist-hip ratio
timeFrame: 6 months (OW-OB and MONW groups)
measure: Blood pressure
timeFrame: Baseline point (all groups)
measure: Blood pressure
timeFrame: 3 months (OW-OB and MONW groups)
measure: Blood pressure
timeFrame: 6 months (OW-OB and MONW groups)
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
Study officials:
References:
citation: 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.