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IRCT2016042813678N12 IRCT 2016-06-29 Vice Chancellor for research of Urmia University of Medical Sciences The effect of branched chain amino acids and vitamin B6 on weight loss The effect of simultaneous oral supplementation with branched chain amino acids and vitamin B6 on body composition, insulin resistance index, serum lipid profile, lipocalin-2 and interleukin-18 in overweight and class1 obese women receiving hypocaloric diet. 2016-07-22 anticipated 42 Complete https://irct.ir/trial/13464 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The block randomization method is designed to randomize subjects into groups. N/A Condition 1: obesity. Condition 2: overweight. Intervention 1: BCAA caplets, 1 gr, 3 times a day , 2 caplets each time, for a month. Intervention 2: placebo caplets of BCAA, 1 gr, 3 times a day, 2 caplets each time, for a month.
public
scientific Dr Saied Ghavamzadeh
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
Urmia Iran (Islamic Republic of) +98 44 3278 0803 ghavamzadeh_s@umsu.ac.ir Urmia University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: female, Childbearing age, BMI=25-35 kg/m², no pregnancy or lactation, absence of endocrinal, thyroid, metabolic and intestinal diseases and diabetes, no follow of specific diet, no follow of heavy sports, no change in cigarettes and caffeine consumption pattern during 4 weeks before study lunch, no weight loss more than 4.5 kg during 2 month before study lunch, no use of any supplementation and eight loss drugs and OCP during and 4 weeks before study, no significant weight change one week before study lunch. Exclusion criteria: any drug or diet side effects, unwillingness to continue the study, pregnancy, menopause, physical activity and diet changes, diseases. 13 years 55 years Female E66.0 E66.9 Obesity due to excess calories Obesity, unspecified Treatment - Drugs Placebo BCAA caplets, 1 gr, 3 times a day , 2 caplets each time, for a month placebo caplets of BCAA, 1 gr, 3 times a day, 2 caplets each time, for a month Body composition. Timepoint: before intervention, 2 weeks after intervention and after interventioin. Method of measurement: BIA analyzer. Insulin resistance index. Timepoint: before and after intervention. Method of measurement: HOMA-IR formula. Lipocalin-2. Timepoint: before and after intervention. Method of measurement: ng/l- Serum samples test. Interleukin-18. Timepoint: before and after intervention. Method of measurement: ng/l- Serum samples test. Lipid profile. Timepoint: before and after intervention. Method of measurement: Serum samples test. Waist–hip ratio. Timepoint: before and after intervention. Method of measurement: tape measure. Vice Chancellor for research of Urmia University of Medical Sciences Approved 2016-04-06 Ethics committee of Urmia University of Medical Sciences Orjhans Street, Resalat Blvd, Urmia Urmia Iran (Islamic Republic of)