Benign breast tumor. Benign neoplasm of breast
Conditions
Interventions
Intervention 1: 1000 mg per day CFA-containing oil (one 1000 mg soft-gel capsule) with 10 IU vitamin E for 13 weeks. Intervention 2: 1000 mg per day combined inert oil (one 1000 mg soft-gel capsule co
Treatment - Drugs
Placebo
1000 mg per day CFA-containing oil (one 1000 mg soft-gel capsule) with 10 IU vitamin E for 13 weeks.
1000 mg per day combined inert oil (one 1000 mg soft-gel capsule containing 350 mg sunflower oil, 350 mg palm olein, 300 mg corn oil) with 10 IU vitamin E for 13 weeks.
Sponsors
Vice-chancellor for Research, Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
25 Years to 47 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Pathology report or sonography confirmation for benign breast tumors; Tendency to participate in study and completing the informed consent form; 25-47 years old; Body mass index (B.M.I) less than the ratio of 35 kilogram to squared meter. Exclusion criteria: Being non-respondent (low compliance) during study; Consumption of less than 85% of supplements (oil capsules); Being in lactation and pregnancy conditions; Being menopause; Taking insulin or oral anti-diabetic drug in each phase of the study by patients; Malignant diseases or any history of malignancy; Thyroid disorders; Acute liver failure such as cirrhosis and viral infection; Getting hormonal disorders before benign breast disease (B.B.D) diagnosis (such as poly cystic ovary syndrome, type 1 diabetes, hypoglycemia, and adrenal gland disorders); Growth hormone disorders and severe congenital anomalies; Peptic ulcer disease and helicobacter pylori infection and any sever gastrointestinal disease such as irritable bowel syndrome and inflammatory bowel disease; Following a vegetarian diet (vegan or lacto-ovo vegetarian); History of chemotherapy, radiotherapy, and hormone therapy; Taking glucocorticoid, anticoagulant, antiepileptic, contraceptive drugs, and hormone replacement therapy (H.R.T); Taking fish liver oil supplement more than 2,000 mg per day; Taking vitamin A supplement; Being heavy smoker in the past year before the diagnosis of B.B.D; Alcohol consumption; Vigorous physical activity.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of metabolic parameters. Timepoint: Baseline and the endpoint of study. Method of measurement: Fasting plasma levels of IGF-1 and glucose and fasting serum levels of IGFBP-3, C-Peptide, Insulin, and PPAR?. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric parameters. Timepoint: Baseline, week 4, week 8, and the end of study. Method of measurement: Waist circumference, body mass index, and waist to hip ratio.;Physiologic variations. Timepoint: Baseline, week 4, week 8, and the end of study. Method of measurement: Systolic and diastolic blood pressure. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed