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

S

Shiraz University of Medical Sciences

Status

Completed

Conditions

Dietary Modification
Obesity

Treatments

Behavioral: MediterrAsian diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02940197
ir.sums.rec.1395.100

Details and patient eligibility

About

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.

Full description

no data yet

Enrollment

145 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

145 participants in 2 patient groups

restricted diet
Experimental group
Description:
Mediterrasian diet according to adjusted ideal body weight with 500 calorie restriction
Treatment:
Behavioral: MediterrAsian diet
Non restricted diet
Experimental group
Description:
Mediterrasian diet according to adjusted ideal body weight without 500 calorie restriction
Treatment:
Behavioral: MediterrAsian diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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