Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
Overview
Brief Summary
This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer.
Detailed Description
PRIMARY OBJECTIVES:
i.) To determine whether nanoemulsion curcumnin modulates pro-inflammatory biomarkers in plasma and breast adipose tissue.
SECONDARY OBJECTIVES include:
ii.) To determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC) in women at high risk for developing breast cancer;
iii.) Evaluate possible correlations between physical factors such as body mass index (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
iv.) Explore additional biomarkers as surrogate endpoints to measure effects of NEC.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive lower dose of nanoemulsion curcumin orally (PO) twice daily (BID) for 3 months.
ARM II: Participants receive 100 mg of nanoemulsion curcumin PO BID for 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
Time Frame: Up to 3 months
Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests.
Secondary Outcomes
- Evaluate possible correlations between physical factors such as body mass (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.(up to 3 months)
Investigators
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center