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

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ClinicalTrials.gov Identifier: NCT02101970
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE March 28, 2014
First Posted Date  ICMJE April 2, 2014
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
Dropout rate [ Time Frame: Up to 6 Months ]
Measured as the number of participants that dropout before diet+intervention period is complete
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2014)
50
Actual Study Completion Date  ICMJE August 27, 2018
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02101970
Other Study ID Numbers  ICMJE STUDY00000703
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Global results will be published.
Responsible Party Carol Fabian, MD, University of Kansas Medical Center
Study Sponsor  ICMJE Carol Fabian, MD
Collaborators  ICMJE DSM Nutritional Products, Inc.
Investigators  ICMJE
Principal Investigator: Carol J. Fabian, M.D. University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date February 2019

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