Breast cancer. Malignant neoplasm of breast
Conditions
Interventions
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 , shoul
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 we
Sponsors
Vice chancellor of research, Iran University of Medical Science
Eligibility
Sex/Gender
Female
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of fasting serum Insulin. Timepoint: Before intervention and 8weeks after the start of intervention. Method of measurement: Microunit/ml - Elisa method. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahsa Raji Lahiji
Iran University of Medical Science
Outcome results
None listed