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

NCT02101970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-01-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    collaborator INDUSTRY

  • Carol Fabian, MD

    lead OTHER

Principal Investigators

  • Carol J. Fabian, M.D. · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-05-31
Completion
2018-08-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101970 on ClinicalTrials.gov