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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-08-27

Brief Summary

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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.

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Detailed Description

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Subjects will all participate in a 6-month weight loss intervention. Subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Omega-3 Fatty Acids

Intervention Type 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)

Diet and Exercise

Intervention Type 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 + 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.

Group Type ACTIVE_COMPARATOR

Placebo Capsule

Intervention Type OTHER

Diet and Exercise

Intervention Type OTHER

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

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Placebo Capsule

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA)

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes