NCT02101970

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Carol Fabian, MD · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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

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

• Breast Cancer

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-05-01
• Completion: 2018-08-27
• First posted: 2014-04-02
• Last updated: 2022-01-24

Locations

1 site across 1 country: United States