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Completed

NCT Number: NCT02940197

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

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.

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Key information

Conditions

Obesity Body Weight Dietary Modification Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shiraz university of medical sciences

Shiraz, Fars, 7194733681, Iran

About this study

no data yet

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MediterrAsian diet

Behavioral

no other description

Primary outcomes

  1. weight loss

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Oct 20, 2016
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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