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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012110511335N2
Enrollment
80
Registered
2013-07-10
Start date
2013-05-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign breast tumor. Benign neoplasm of breast

Interventions

Intervention 1: Control groups: 480 ml similar to intervention(suger: 55gr, vitamin c: 80 mg) both in lunch & dinner meal ( a glass in each meal equal to 240ml) for 8 weeks. Intervention 2: Interventi
Carbohydrates:55gr/500ml
vitamin c:80mg/500ml
Calcium:50mg/500ml
Sodium:100mg/500ml
fat:10mg/500ml) both in lunch & dinner meal ( a glass in each meal equal to 240ml) for 8 weeks.
Treatment - Drugs
Control groups: 480 ml similar to intervention(suger: 55gr, vitamin c: 80 mg) both in lunch & dinner meal ( a glass in each meal equal to 240ml) for 8 weeks.
Intervention Group: 480 ml berberis vulgaris juice(protein:600mg/500ml

Sponsors

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

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Gene expression of PPAR-gamma. Timepoint: Baseline and endpoint of the intervention. Method of measurement: Real time RT-PCR.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 1, 2026