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

NCT02101970 | Completed

• 1 other identifier: STUDY00000703
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer risk; DHA; Omega-3 Fatty Acids; EPA; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Dropout rate

  Measured as the number of participants that dropout before diet+intervention period is complete

  Up to 6 Months

Secondary Outcomes (7)

• Study design feasibility

  Up to 6 months

• Modulation of breast cancer risk biomarkers

  Change from Baseline to 6 Months

• Modulation of breast cancer risk biomarkers in benign breast tissue

  Change from Baseline to 6 Months

• Modulation of breast cancer risk biomarkers

  Change from Baseline to 12 Months

• Modulation of breast cancer risk biomarkers in benign breast tissue

  Change from Baseline to 12 Months

Study Arms (2)

Weight Loss + Omega-3 FA

EXPERIMENTAL

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; Other: Diet and Exercise

Weight Loss + Placebo

ACTIVE COMPARATOR

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

Interventions

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

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)

Also known as: Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)

Weight Loss + Omega-3 FA

Placebo Capsule OTHER

Weight Loss + Placebo

Diet and Exercise OTHER

Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.

Weight Loss + Omega-3 FA; Weight Loss + Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carol Fabian, MD: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center, Breast Cancer Prevention Center

Kansas City, Kansas, 66205, United States

Location

Related Publications (1)

• Fabian CJ, Befort CA, Phillips TA, Nydegger JL, Kreutzjans AL, Powers KR, Metheny T, Klemp JR, Carlson SE, Sullivan DK, Zalles CM, Giles ED, Hursting SD, Hu J, Kimler BF. Change in Blood and Benign Breast Biomarkers in Women Undergoing a Weight-Loss Intervention Randomized to High-Dose omega-3 Fatty Acids versus Placebo. Cancer Prev Res (Phila). 2021 Sep;14(9):893-904. doi: 10.1158/1940-6207.CAPR-20-0656. Epub 2021 Jul 9.

  PMID: 34244155 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Interventions

Fatty Acids, Omega-3; Eicosapentaenoic Acid; Docosahexaenoic Acids; Diet; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carol J. Fabian, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: August 27, 2018
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)