Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2016

Detailed Description

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.

Interventions

  • Dietary Supplement: Omega-3 Fatty Acids
    • 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: Placebo Capsule
  • Other: Diet and Exercise
    • Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.

Arms, Groups and Cohorts

  • Experimental: Weight Loss + Omega-3 FA
    • Participants will be instructed to follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of Omega-3 FA (fatty acids) a day beginning 2 weeks after starting their diet and exercise routine. Omega-3 FA will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.Each 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)
  • Active Comparator: Weight Loss + Placebo
    • Participants will be instructed to exercise and follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of placebo a day beginning 2 weeks after starting their diet and exercise routine. Placebo capsule will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.

Clinical Trial Outcome Measures

Primary Measures

  • Dropout rate
    • Time Frame: Up to 6 Months
    • Measured as the number of participants that dropout before diet+intervention period is complete

Secondary Measures

  • Study design feasibility
    • 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
  • Modulation of breast cancer risk biomarkers
    • Time Frame: Change from Baseline to 6 Months
    • Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
  • Modulation of breast cancer risk biomarkers in benign breast tissue
    • Time Frame: Change from Baseline to 6 Months
    • Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
  • Modulation of breast cancer risk biomarkers
    • Time Frame: Change from Baseline to 12 Months
    • Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
  • Modulation of breast cancer risk biomarkers in benign breast tissue
    • Time Frame: Change from Baseline to 12 Months
    • Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
  • Weight gain
    • Time Frame: Change from 6 Months to 12 Months
    • Measure change in weight in participants during the 6-12 month maintenance phase
  • Change in Gut Microbiome
    • Time Frame: Change from Baseline to Month 6
    • Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio

Participating in This Clinical Trial

Inclusion Criteria

  • Evidence of Hyperplasia with Masood score of 13 or higher and 500 or more epithelial cells on cytology slide of screening Random Periareolar Fine Needle Aspiration (RPFNA) – Access to smart phone and or computer – Willing to comply with diet, exercise and lifestyle modification during weight reduction and maintenance phase. – Willing to start the dietary and exercise intervention within 9 months of RPFNA – Willing to complete quality of life questionnaires at multiple visits – Willing to have a medical history and physical at multiple visits – Willing to have an additional RPFNA at two additional visits – Be willing to have blood drawn at multiple visits – Willing to sign and able to understand consent for the RPFNA's and study participation – Reasonable hematopoetic, kidney and liver function consistent with safe participation on this trial. Exclusion Criteria:

  • Having taken medications that seriously affect metabolism such as steroids, dexatrim or other diet drugs within 3 weeks of study registration – Have changed dose or type of hormone supplementation within 3 months – Currently receiving other investigational agents – Have been on a chemoprevention trial within 6 months or taken a Selective Estrogen Receptor Modulator or aromatase inhibitor within last 6 months. – Need for chronic use of aspirin, nonsteroidal anti-inflamatory drug (NSAID) or other anti-inflammatory agents – Taking metformin, or other diabetes medications – Taking statins – Unable to participate in moderate intensity exercise (walking, treadmill, elliptical, water aerobics) – Would be unable to participate, by phone, in weekly phone call sessions – Cells suspicious for malignancy as assessed by cytotechnologist or cytopathologist.

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Carol Fabian, MD
  • Collaborator
    • DSM Nutritional Products, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit – University of Kansas Medical Center
  • Overall Official(s)
    • Carol J. Fabian, M.D., Principal Investigator, University of Kansas Medical Center

Citations Reporting on Results

Fabian CJ, Befort CA, Phillips TA, Nydegger JL, Kreutzjans AL, Powers KR, Metheny T, Klemp JR, Carlson SE, Sullivan DK, Zalles CM, Giles ED, Hursting SD, Hu J, Kimler BF. Change in Blood and Benign Breast Biomarkers in Women Undergoing a Weight-Loss Intervention Randomized to High-Dose omega-3 Fatty Acids versus Placebo. Cancer Prev Res (Phila). 2021 Sep;14(9):893-904. doi: 10.1158/1940-6207.CAPR-20-0656. Epub 2021 Jul 9.

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