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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Kansas
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT02101970
First received: March 28, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

The purpose of this study is to determine if high dose omega-3 fatty acids when added to a weight loss program are well tolerated in the study population and if they increase the favorable change in blood and tissue breast cancer risk factors in the associated with weight loss alone.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: Omega-3 Fatty Acids
Other: Placebo Capsule
Other: Diet and Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:

Primary Outcome Measures:
  • Dropout rate [ Time Frame: Up to 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure change in fasting and postprandial blood inflammatory, and risk biomarkers

  • Weight gain [ Time Frame: Change from 6 Months to 12 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: April 2016
Estimated Primary Completion Date: April 2016 (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
Genders 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

Contacts
Contact: Bruce Kimler, PhD (913) 588-4523 bkimler@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center, Breast Cancer Prevention Center Recruiting
Kansas City, Kansas, United States, 66205
Contact: Jennifer Nydegger    913-588-3963    jnydegger@kumc.edu   
Sponsors and Collaborators
Carol Fabian, MD
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Carol J. Fabian, M.D. University of Kansas
  More Information

No publications provided

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT02101970     History of Changes
Other Study ID Numbers: STUDY00000703
Study First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
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 August 18, 2014