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| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Dropout rate | Measured as the number of participants that dropout before diet+intervention period is complete | Up to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Study design feasibility | 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 | Up to 6 months |
| Modulation of breast cancer risk biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol J. Fabian, M.D. | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center, Breast Cancer Prevention Center | Kansas City | Kansas | 66205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34244155 | Result | 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. |
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Global results will be published.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D015118 | Eicosapentaenoic Acid |
| D004281 | Docosahexaenoic Acids |
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo Capsule | Other |
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| 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. |
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Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers |
| Change from Baseline to 6 Months |
| Modulation of breast cancer risk biomarkers in benign breast tissue | Measure change in fasting and postprandial blood inflammatory, and risk biomarkers | Change from Baseline to 6 Months |
| Modulation of breast cancer risk biomarkers | Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers | Change from Baseline to 12 Months |
| Modulation of breast cancer risk biomarkers in benign breast tissue | Measure change in fasting and postprandial blood inflammatory, and risk biomarkers | Change from Baseline to 12 Months |
| Weight gain | Measure change in weight in participants during the 6-12 month maintenance phase | Change from 6 Months to 12 Months |
| Change in Gut Microbiome | Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio | Change from Baseline to Month 6 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D015777 | Eicosanoids |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |