Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers

NCT ID: NCT02940197

Last Updated: 2019-04-05

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

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-03-31

Brief Summary

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Background: Obesity treatment should be individualized since some calorie restricted diet doesn't work for some individuals.

Objective: we assess the effect of two different calorie restriction with MediterrAsian diet on weight loss of FTO rs9939609 carriers with overweight.

Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly allocated in two interventional group \[group 1: Mediterrasian diet according to adjusted ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories restriction (NRD)+ Moderate physical activity\]. Anthropometric indices will be assesses for all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly. Metabolic indices, physical activity and psychologic aspects will be assesses at baseline and the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0, 30 and 60. At the end of the study, we compare carriers with different alleles (AA+TA and TT) in two intervention groups to find out which calorie restriction is appropriate for each genotype. Significant p-value is less than 0.05.

Detailed Description

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no data yet

Conditions

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Obesity Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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restricted diet

Mediterrasian diet according to adjusted ideal body weight with 500 calorie restriction

Group Type EXPERIMENTAL

MediterrAsian diet

Intervention Type BEHAVIORAL

no other description

Non restricted diet

Mediterrasian diet according to adjusted ideal body weight without 500 calorie restriction

Group Type EXPERIMENTAL

MediterrAsian diet

Intervention Type BEHAVIORAL

no other description

Interventions

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MediterrAsian diet

no other description

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI range: 24.9-29.9 (overweight)
* Ethnicity: Persian

Exclusion Criteria

* History of any metabolic diseases like Diabetes, CVD, Thyroid problems and ... .
* History of depression
* Pregnancy, trying to become pregnant or breast feeding
* Smoking
* Use of alcohol
* Significant weight loos during last two months (\>5 kilograms)
* being on a diet during last two months
* Use of any drug or supplement
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mahsa Mehrdad

Ph.D Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shiraz university of medical sciences

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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ir.sums.rec.1395.100

Identifier Type: -

Identifier Source: org_study_id

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