The effects of berberis vulgaris juice on plasma hormonal-metabolic parameters and PPAR-? gene expression level in patients with benign breast tumor: a randomized controlled clinical trial

Phase 2

Completed

Conditions: Benign breast tumor.
Benign neoplasm of breast

Registration Number: IRCT2012110511335N2

Lead Sponsor: Vice Chancellor for research, Faculty of Nutrition, Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Participants: The inclusion criteria: Histopathological confirmed benign breast; 15-45 years old; Tendency to corporation in study; Completing informed consent form; Passing atleast 2 year from diagnosing disease; BMI less than the ratio of 35 kilogram to squared meter; Moderately active; Lack of menopause.
Exclusion criteria: Energy intake range out of 500-3500; History of consumption cigarette in recent 1 year before diagnosing the disease; Acute chronic disease like other cancers; Cardiovascular disease like: Renal disease, liver disease, Hyperthyroidism and other hormonal disorder before diagnosing the disease (pcos, type 1 diabetes, Hypoglycemia, adrenal gland malfunction ); Having any kind of bleeding & trauma by self reporting or physician; History of other benign neoplasms; Pregnancy and lactation; Consumption of drugs;like glucocorticoids, blood anticoagulants, Epilepsy-related drugs, HRTs, Fish oil supplements more than 2000 mg per day.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma levels of hormonal-metabolic parameters (IGF-1, Insulin, C-peptide, FBS, IGFBP-1, IGFBP-3) and plasma level and gene expression of PPAR-gamma. Timepoint: Baseline and endpoint of the intervention. Method of measurement: Electrochemiluminescence.

Secondary Outcome Measures