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

NCT02940197 | Completed DMC

• 1 other identifier: ir.sums.rec.1395.100
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Dietary Modification

Keywords

overweight; Caloric Restriction

Outcome Measures

Primary Outcomes (1)

• weight loss

  2 months

Study Arms (2)

restricted diet

EXPERIMENTAL

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

Behavioral: MediterrAsian diet

Non restricted diet

EXPERIMENTAL

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

Behavioral: MediterrAsian diet

Interventions

MediterrAsian diet BEHAVIORAL

no other description

Non restricted diet; restricted diet

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz university of medical sciences

Shiraz, Fars, 7194733681, Iran

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D Candidate

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 20, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: March 1, 2019
• Last Updated: April 5, 2019

Record last verified: 2017-09

Locations

IR (1)