The purpose of this study is to determine if high dose supplementation with the omega-3 fatty acids EPA and DHA, when added to a weight loss program, is well tolerated in the study population and if there is an increase in the favorable change in blood and tissue breast cancer risk factors when compared to weight loss alone.
Subjects will all participate in a 6-month weight loss intervention. Subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
46
Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)
Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.
University of Kansas Medical Center, Breast Cancer Prevention Center
Kansas City, Kansas, United States
Dropout rate
Measured as the number of participants that dropout before diet+intervention period is complete
Time frame: Up to 6 Months
Study design feasibility
Based on eligibility criteria, study procedures and participation of subjects the study design will be measured to see if it will practically work with a larger study population
Time frame: Up to 6 months
Modulation of breast cancer risk biomarkers
Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from Baseline to 6 Months
Modulation of breast cancer risk biomarkers in benign breast tissue
Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from Baseline to 6 Months
Modulation of breast cancer risk biomarkers
Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from Baseline to 12 Months
Modulation of breast cancer risk biomarkers in benign breast tissue
Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from Baseline to 12 Months
Weight gain
Measure change in weight in participants during the 6-12 month maintenance phase
Time frame: Change from 6 Months to 12 Months
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Change in Gut Microbiome
Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio
Time frame: Change from Baseline to Month 6