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IRCT20091114002709N49 IRCT 2018-05-18 Iran University of Medical Sciences Effect of symbiotic supplement on breast cancer recurrence Effect of symbiotic supplement on serum adiponectin, hs-CRP, TNF-α, Apo A1 and Apo-B100 concentration in obese and overweight breast cancer survivors with low calorie diet 2018-05-30 anticipated 76 Complete https://irct.ir/trial/31044 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: use of stratified randomization based on BMI (BMI=25-30 and BMI=30-40), Blinding description: In this study, participants, major researcher, data collectors were kept blind to study groups. N/A Breast cancer. Intervention 1: Intervention group: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is participants privacy security
public Mahsa Raji Lahiji
Martyr Hemmat Highway, the Highway of Sheikh Fazullah Nuri and martyr Chamran, School of public health , nutrition group
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 4401 3375 Rajimahsa@yahoo.com Iran University of Medical Sciences 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) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4814 zarrati-ms@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Female breast cancer survivors (or Cessation of menstruation for at least 6 months prior to chemotherapy) Age range (50-75) BMI = 25 - 40 Kg/m2 At least one month has passed since the last radiotherapy Complete treatment of stage 1 - 4 breast cancer survivors Type of breast cancer : ER/PR+ and HER2- Willingness to cooperate and sign a written informed consent 50 years 75 years Female History of Diabetes, acute heart failure, cirrhosis hepatic, acute and chronic renal failure History of autoimmune and infectious disease weight loss diet during the 6 months prior to study Smoking Alcohol consumption Nutrition supplement consumption C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: 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. Adiponectin. Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Elisa method. Tumor Necrosis Factor alpha (TNF-α). Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Elisa method. High-sensitivity C-reactive protein (hs-CRP). Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Elisa method. Apolipoprotein-A1 (Apo-A1). Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Elisa method. Apolipoprotein-B100 (Apo-B100). Timepoint: Before intervention and 8 weeks after the start of intervention. Method of measurement: Elisa method. Iran University of Medical Sciences Approved 2018-04-20 Ethics committee of Iran University of Medical Science Martyr Hemmat Highway, the highway of Sheikh Fazlullah Nuri and martyr Chamran Tehran Tehran Iran (Islamic Republic of)