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

Not Applicable

Completed

• Conditions: Obesity; Dietary Modification
• Interventions: Behavioral: MediterrAsian diet

• Registration Number: NCT02940197
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

no data yet

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Primary Completion: 2017-05
• Status Verified: 2017-09
• Study Completion: 2019-03
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
restricted diet	MediterrAsian diet	Mediterrasian diet according to adjusted ideal body weight with 500 calorie restriction
Non restricted diet	MediterrAsian diet	Mediterrasian diet according to adjusted ideal body weight without 500 calorie restriction

Primary Outcome Measures

Name	Time	Method
weight loss	2 months

Trial Locations

Locations (1)

Shiraz university of medical sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of