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

March 28, 2014
March 28, 2014
March 2014
April 2016   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Breast Cancer
  • 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: 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.
  • 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)
    Interventions:
    • Dietary Supplement: Omega-3 Fatty Acids
    • Other: Diet and Exercise
  • 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.
    Interventions:
    • Other: Placebo Capsule
    • Other: Diet and Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2016
April 2016   (final data collection date for primary outcome measure)

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.
Female
45 Years to 70 Years
Yes
Contact: Bruce Kimler, PhD (913) 588-4523 bkimler@kumc.edu
United States
 
NCT02101970
STUDY00000703
No
Carol Fabian, MD, University of Kansas Medical Center Research Institute
Carol Fabian, MD
DSM Nutritional Products, Inc.
Principal Investigator: Carol J. Fabian, M.D. University of Kansas
University of Kansas
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP