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IRCT2015090223861N1 IRCT 2017-02-01 Vice chancellor of research, Iran University of Medical Science Effect of symbiotic supplement on breast cancer recurrence Effect of symbiotic supplement on serum insulin , IGF-1 and some sex hormones concentration in obese and overweight breast cancer survivors with low calorie diet 2017-04-09 anticipated 76 Complete https://irct.ir/trial/20285 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: use of stratified randomization based on BMI (BMI=25-30 and BMI=30-40). N/A Breast cancer. Intervention 1: Intervention group: Weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Participants in both; intervention and control groups refer to the dietitian in the doctor najafi's clinic one time every four weeks to change their diet. Calorie intake of participants is calculated base on Harris-Benedict Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + consumption of symbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) microbal population : 1010 CFU/gr and 38/5 mg fructooligosaccharide, once daily for 8 weeks. symbiotic supplement will be purchase from Zist takhmir company. Intervention 2: Control group : weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Participants in both; intervention and control groups refer to the dietitian in the doctor najafi's clinic one time every four weeks to change their diet. Calorie intake of participants is calculated based on Harris-Benedict Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + placebo consists of ( lactose,Magnesium Stearate, talk, silicon dioxide) once daily for 8 weeks. Placebo will be purchase from Zist takhmir company.
public Mahsa Raji Lahiji
Martyr Hemmat Highway, the highway of Sheikh Fazlullah Nuri and martyr Chamran, School of public health , nutrition group
Tehran Iran (Islamic Republic of) +98 21 8670 4814 rajimahsa@yahoo.com Iran University of Medical Science scientific Doctor Mitra Zarrati
Martyr Hemmat Highway, the highway of Sheikh Fazlullah Nuri and martyr Chamran, school of public health, nutrition group
Tehran Iran (Islamic Republic of) +98 21 8670 4814 zarrati_ms@yahoo.com Iran University of Medical Science Iran (Islamic Republic of) Inclusion criteria : 1- Female breast cancer survivors (or Cessation of menstruation for at least 6 months prior to chemotherapy); 2- Age range (50-75); 3- BMI = 25 - 40 Kg/m2; 4- At least one month has passed since the last radiotherapy; 5- Complete treatment of stage 1 - 4 breast cancer survivors; 6- Type of breast cancer : ER/PR+ and HER2-; 7- Willingness to cooperate and sign a written informed consent Non-inclusion criteria: 1- History of Diabetes, acute heart failure, cirrhosis hepatic, acute and chronin renal failure; 2- History of autoimmune and infectious disease; 3- Have a weight loss diet during the 6 months prior to study; 4- Smoking; 5- Alcohol consumption; 6- Nutrition supplement consumption Exclusion criteria : 1- Metastasis during the study; 2- Failure to follow the weight loss diet; 3-Consumption less than 46 capsules of 56 capsules at the end of study; 4-Infectious disease during the study; 5- Consumption of probiotic foods during the study; 6- Consumption of fibre supplement during the study; 7- Consumption of herbal supplement; 8- Patient at any time can leave the study freely 50 years 75 years Female C50-C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: Weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Participants in both; intervention and control groups refer to the dietitian in the doctor najafi's clinic one time every four weeks to change their diet. Calorie intake of participants is calculated base on Harris-Benedict Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + consumption of symbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) microbal population : 1010 CFU/gr and 38/5 mg fructooligosaccharide, once daily for 8 weeks. symbiotic supplement will be purchase from Zist takhmir company. Control group : weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Participants in both; intervention and control groups refer to the dietitian in the doctor najafi's clinic one time every four weeks to change their diet. Calorie intake of participants is calculated based on Harris-Benedict Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + placebo consists of ( lactose,Magnesium Stearate, talk, silicon dioxide) once daily for 8 weeks. Placebo will be purchase from Zist takhmir company. Concentration of fasting serum Insulin. Timepoint: Before intervention and 8weeks after the start of intervention. Method of measurement: Microunit/ml - Elisa method. Estradiol. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Pg/ml - Elisa method. Insulin resistance. Timepoint: Befor intervention and 8 weeks after the start of intervention. Method of measurement: Calculate by the formula. Testosterone. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: ng/ml - ELISA method. DHEA-S. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Mg/ml - EILSA method. SHBG. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: nmol/ml - ELISA method. IGF-1. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: ng/ml - ELISA method. IGFBP-3. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: ng/ml - ELISA method. HbA1c. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Biochemical method. Vice chancellor of research, Iran University of Medical Science Approved 2016-11-19 Ethics committee of Iran University of Medical Science Martyr Hemmat Highway, the highway of Sheikh Fazlullah Nuri and martyr Chamran tehran Iran (Islamic Republic of)