N/A
N=24
Dietary Fat, Eicosanoids and Breast Cancer Risk
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01824498 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Plasma Sex Hormone Levels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Fat diet (Other); Low Fat high n3 diet (Other); High Fat Diet (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- USDA Grand Forks Human Nutrition Research Center
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Sex Hormone Levels |
— | — |
| PRIMARY E2 |
52.8; 35.6; 39.8 | — |
Summary
The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women
- 45 to 70 years old,
- at least one year since their last menstrual period
- not using hormone replacement therapy,
- BMI between 19 -29
- willingness to discontinue use of over-the-counter medications with anti-prostaglandin activity such as aspirin or non-steroidal anti-inflammatory medications
- consumption of a "Typical " American diet with no unusual dietary practices such as compliance with a strict vegetarian diet
- willingness to comply with the demands of the experimental protocol.
Exclusion Criteria
- Smoking
- Known disease process, and 3) Use of prescription medications, including hormone replacement therapy.
Data sourced from ClinicalTrials.gov (NCT01824498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.