University of Kansas Medical Center, Breast Cancer Prevention Center
Kansas City, Kansas, 66205, United States
NCT Number: NCT02101970
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.
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Notify Me45 year–70 year
Female
Interventional
Not applicable
Kansas City, Kansas, 66205, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Other names: Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)
Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.
Time frame: Up to 6 Months
Measured as the number of participants that dropout before diet+intervention period is complete
Time frame: Up to 6 months
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: Change from Baseline to 6 Months
Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from Baseline to 6 Months
Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from Baseline to 12 Months
Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from Baseline to 12 Months
Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
Time frame: Change from 6 Months to 12 Months
Measure change in weight in participants during the 6-12 month maintenance phase
Time frame: Change from Baseline to Month 6
Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio
Carol Fabian, MD
Other
Randomized Pilot Trial of Omega-3 Fatty Acids or Placebo in Peri- or Post-Menopausal Women at High Risk for Breast Cancer Undergoing a Weight Loss Intervention
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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