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Completed

NCT Number: NCT02101970

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

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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Key information

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Breast Cancer Prevention Center

Kansas City, Kansas, 66205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

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)

Placebo capsule

Other

Diet and Exercise

Other

Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.

Primary outcomes

  1. Dropout rate

    Time frame: Up to 6 Months

    Measured as the number of participants that dropout before diet+intervention period is complete

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Weight gain

    Time frame: Change from 6 Months to 12 Months

    Measure change in weight in participants during the 6-12 month maintenance phase

  7. 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

Sponsors and collaborators

Lead sponsor

Carol Fabian, MD

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Apr 2, 2014
Registry last updated
Jan 24, 2022

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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