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Completed

NCT Number: NCT04402697

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary and physical activity intervention

Other

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.

Primary outcomes

  1. 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

  2. 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. 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

  4. Weight

    Time frame: Baseline point (all groups)

    Weight (kg)

  5. Weight

    Time frame: 3 months (OW-OB and MONW groups)

    Weight (kg)

  6. Weight

    Time frame: 6 months (OW-OB and MONW groups)

    Weight (kg)

  7. Body Mass Index (BMI)

    Time frame: Baseline point (all groups)

    Weight and height will be combined to report BMI in kg/m^2).

  8. 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).

  9. 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).

  10. Body composition

    Time frame: Baseline point (all groups)

    Body composition (fat mass in kg) measured using a DXA scanner

  11. Body composition

    Time frame: 3 months (OW-OB and MONW groups)

    Body composition (fat mass in kg) measured using a DXA scanner

  12. Body composition

    Time frame: 6 months (OW-OB and MONW groups)

    Body composition (fat mass in kg) measured using a DXA scanner

  13. 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

  14. 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

  15. 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

  16. Circulating gamma-glutamyl transpeptidase (GGT)

    Time frame: Baseline point (all groups)

    GGT measured in U/L

  17. Circulating gamma-glutamyl transpeptidase (GGT)

    Time frame: 3 months (OW-OB and MONW groups)

    GGT measured in U/L

  18. Circulating gamma-glutamyl transpeptidase (GGT)

    Time frame: 6 months (OW-OB and MONW groups)

    GGT measured in U/L

Secondary outcomes

  1. Height

    Time frame: Baseline point (all groups)

    Height (m)

  2. Height

    Time frame: 3 months (OW-OB and MONW groups)

    Height (m)

  3. Height

    Time frame: 6 months (OW-OB and MONW groups)

    Height (m)

  4. Waist-hip ratio

    Time frame: Baseline point (all groups)

    Waist-hip ratio

  5. Waist-hip ratio

    Time frame: 3 months (OW-OB and MONW groups)

    Waist-hip ratio

  6. Waist-hip ratio

    Time frame: 6 months (OW-OB and MONW groups)

    Waist-hip ratio

  7. Blood pressure

    Time frame: Baseline point (all groups)

    Blood pressure (mm Hg)

  8. Blood pressure

    Time frame: 3 months (OW-OB and MONW groups)

    Blood pressure (mm Hg)

  9. Blood pressure

    Time frame: 6 months (OW-OB and MONW groups)

    Blood pressure (mm Hg)

Sponsors and collaborators

Lead sponsor

University of the Balearic Islands

Other

Registry information

Official study title

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

Acronym: METAHEALTH

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 27, 2020
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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