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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940197
• Other study ID #: ir.sums.rec.1395.100
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2019

Study information

• Verified date: September 2017
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

no data yet

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification
• Obesity

Intervention

Behavioral:
• MediterrAsian diet
no other description

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz university of medical sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		2 months