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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT02101970
First received: March 28, 2014
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Breast Cancer
Dietary Supplement: Omega-3 Fatty Acids
Other: Placebo Capsule
Other: Diet and Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

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


Secondary Outcome 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


Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101970

Locations
United States, Kansas
University of Kansas Medical Center, Breast Cancer Prevention Center
Kansas City, Kansas, United States, 66205
Sponsors and Collaborators
Carol Fabian, MD
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Carol J. Fabian, M.D. University of Kansas Medical Center
  More Information

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02101970     History of Changes
Other Study ID Numbers: STUDY00000703
Study First Received: March 28, 2014
Last Updated: April 19, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Global results will be published.

Keywords provided by University of Kansas Medical Center:
Breast cancer risk
DHA
Omega-3 Fatty Acids
EPA
Weight Loss

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 26, 2017