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

January 6, 2022 updated by: Carol Fabian, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66205
        • University of Kansas Medical Center, Breast Cancer Prevention Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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 Names:
  • Eicosapentaenoic Acid (EPA)
  • Docosahexaenoic Acid (DHA)
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.
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.
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.
Other: Placebo Capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 6 months
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
Change from Baseline to 6 Months
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
Change from Baseline to 6 Months
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
Change from Baseline to 12 Months
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
Change from Baseline to 12 Months
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 from 6 Months to 12 Months
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
Change from Baseline to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Fabian, MD

Collaborators

DSM Nutritional Products, Inc.

Investigators

  • Principal Investigator: Carol J. Fabian, M.D., University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 27, 2018

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Global results will be published.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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