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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-25

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Volunteers are assigned to three groups for the duration of the study:

1. Normal-weight
2. Overweight-Obese
3. Metabolically obese normal-weight

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Normal-weight (NW)

Individuals with BMI\<25 kg/m2

Group Type NO_INTERVENTION

No interventions assigned to this group

Overweight-Obese (OW-OB)

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

Group Type EXPERIMENTAL

Dietary and physical activity intervention

Intervention Type 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.

Metabolically obese normal-weight (MONW)

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.

Group Type EXPERIMENTAL

Dietary and physical activity intervention

Intervention Type 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.

Interventions

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Dietary 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes