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

Primary Purpose

Obesity, Dietary Modification

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
MediterrAsian diet
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring overweight, Caloric Restriction

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shiraz university of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

restricted diet

Non restricted diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

Full Information

First Posted
October 19, 2016
Last Updated
April 3, 2019
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02940197
Brief Title
Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dietary Modification
Keywords
overweight, Caloric Restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
restricted diet
Arm Type
Experimental
Arm Description
Mediterrasian diet according to adjusted ideal body weight with 500 calorie restriction
Arm Title
Non restricted diet
Arm Type
Experimental
Arm Description
Mediterrasian diet according to adjusted ideal body weight without 500 calorie restriction
Intervention Type
Behavioral
Intervention Name(s)
MediterrAsian diet
Intervention Description
no other description
Primary Outcome Measure Information:
Title
weight loss
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Shiraz university of medical sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
7194733681
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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