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Overweight and ObesityMETAHEALTHNCT04402697

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

A study testing Dietary and physical activity intervention in people with Overweight and Obesity, run by University of the Balearic Islands at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Dietary and physical activity intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
25 May 2016to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of the Balearic Islands

    Palma de Mallorca, Balearic Islands, 07122

Other trials in Spain

About this study

Official title: 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.

Being tested
Dietary and physical activity intervention
Keywords
Overweight, Obesity, Blood cells, Metabolic health, Weight loss
Medical subject headings
Overweight, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04402697
Study groupRoleWhat they receive
Normal-weight (NW)No interventionIndividuals with BMI<25 kg/m2
Overweight-Obese (OW-OB)ExperimentalIndividuals 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
Receives: Other: Dietary and physical activity intervention
Metabolically obese normal-weight (MONW)ExperimentalIndividuals 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.
Receives: Other: Dietary and physical activity intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline point (all groups)

  2. 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

    Measured: 3 months (OW-OB and MONW groups)

  3. 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

    Measured: 6 months (OW-OB and MONW groups)

  4. Weight

    Weight (kg)

    Measured: Baseline point (all groups)

  5. Weight

    Weight (kg)

    Measured: 3 months (OW-OB and MONW groups)

  6. Weight

    Weight (kg)

    Measured: 6 months (OW-OB and MONW groups)

  7. Body Mass Index (BMI)

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

    Measured: Baseline point (all groups)

  8. Body Mass Index (BMI)

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

    Measured: 3 months (OW-OB and MONW groups)

  9. Body Mass Index (BMI)

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

    Measured: 6 months (OW-OB and MONW groups)

  10. Body composition

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

    Measured: Baseline point (all groups)

  11. Body composition

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

    Measured: 3 months (OW-OB and MONW groups)

  12. Body composition

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

    Measured: 6 months (OW-OB and MONW groups)

  13. 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

    Measured: Baseline point (all groups)

  14. 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

    Measured: 3 months (OW-OB and MONW groups)

  15. 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

    Measured: 6 months (OW-OB and MONW groups)

  16. Circulating gamma-glutamyl transpeptidase (GGT)

    GGT measured in U/L

    Measured: Baseline point (all groups)

  17. Circulating gamma-glutamyl transpeptidase (GGT)

    GGT measured in U/L

    Measured: 3 months (OW-OB and MONW groups)

  18. Circulating gamma-glutamyl transpeptidase (GGT)

    GGT measured in U/L

    Measured: 6 months (OW-OB and MONW groups)

Secondary outcomes (9)

  1. Height

    Height (m)

    Measured: Baseline point (all groups)

  2. Height

    Height (m)

    Measured: 3 months (OW-OB and MONW groups)

  3. Height

    Height (m)

    Measured: 6 months (OW-OB and MONW groups)

  4. Waist-hip ratio

    Waist-hip ratio

    Measured: Baseline point (all groups)

  5. Waist-hip ratio

    Waist-hip ratio

    Measured: 3 months (OW-OB and MONW groups)

  6. Waist-hip ratio

    Waist-hip ratio

    Measured: 6 months (OW-OB and MONW groups)

  7. Blood pressure

    Blood pressure (mm Hg)

    Measured: Baseline point (all groups)

  8. Blood pressure

    Blood pressure (mm Hg)

    Measured: 3 months (OW-OB and MONW groups)

  9. Blood pressure

    Blood pressure (mm Hg)

    Measured: 6 months (OW-OB and MONW groups)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start25 May 2016
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04402697
Sponsor's protocol ID
nºIB 3216/16 PI
Acronym
METAHEALTH
Status last verified
Jul 2022
First submitted
13 May 2020
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD will be shared in due time if considered relevant for other research. With our current objectives, it is not considered necessary.

Publications

  • 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.

    PubMed 33978191

Questions about this trial

What is this clinical trial studying?

A study testing Dietary and physical activity intervention in people with Overweight and Obesity, run by University of the Balearic Islands at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells (time frame: Baseline point (all groups)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04402697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.

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