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

April 3, 2019 updated by: Mahsa Mehrdad, Shiraz University of Medical Sciences

Comparison of the Effect of MediterrAsian Diet With Two Different Calorie Restriction on Anthropometric Indices in Carriers of FTO rs9939609 Polymorphism With Overweigh: Toward Personalized Nutrition

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

no data yet

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Minimum age: 20 years Maximum age: 45 years Gender: Both Accepts Healthy Volunteers?: Yes

Criteria: 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: restricted diet
Mediterrasian diet according to adjusted ideal body weight with 500 calorie restriction
Behavioral: MediterrAsian diet
no other description
Experimental: Non restricted diet
Mediterrasian diet according to adjusted ideal body weight without 500 calorie restriction
Behavioral: MediterrAsian diet
no other description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ir.sums.rec.1395.100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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