Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2004-01-31
2010-11-30
Brief Summary
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Detailed Description
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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. The primary endpoints to be evaluated include plasma and urinary sex hormone concentrations as follows:
Endpoints associates with increased risk factors for breast cancer risk: plasma estradiol (E2), estrone (E1), estrone sulfate (E1 sulfate), testosterone, androstenedione, sex hormone binding globulin (SHBG), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), Measures of estrogen action: plasma follicle stimulating hormone (FSH), urinary estrogen metabolites.
Measures of systemic arachidonic acid-derived eicosanoids: urinary bicyclo-prostaglandin E2 (PGEa), 2,3-dinor thromboxane B2 (TXB2).
Measures reflecting influence of dietary fat and fatty acid intake: plasma phospholipid, cholesterol ester, triglyceride and free fatty acid composition.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Low Fat, High Fat, Low Fat High Omega 3
See Intervention Description
Low Fat diet
Low fat diet = 20% fat
Low Fat high n3 diet
Low Fat high n3 diet = 20% fat + 3% n3
High Fat Diet
High Fat Diet = 40% fat
Low Fat, Low Fat High Omega 3, High Fat
See Intervention Description
Low Fat diet
Low fat diet = 20% fat
Low Fat high n3 diet
Low Fat high n3 diet = 20% fat + 3% n3
High Fat Diet
High Fat Diet = 40% fat
High Fat, Low Fat, Low Fat High Omega 3
See Intervention Description
Low Fat diet
Low fat diet = 20% fat
Low Fat high n3 diet
Low Fat high n3 diet = 20% fat + 3% n3
High Fat Diet
High Fat Diet = 40% fat
High Fat, Low fat High Omega 3, Low Fat
See Intervention Description
Low Fat diet
Low fat diet = 20% fat
Low Fat high n3 diet
Low Fat high n3 diet = 20% fat + 3% n3
High Fat Diet
High Fat Diet = 40% fat
Low Fat High Omega 3, High Fat, Low Fat
See Intervention Description
Low Fat diet
Low fat diet = 20% fat
Low Fat high n3 diet
Low Fat high n3 diet = 20% fat + 3% n3
High Fat Diet
High Fat Diet = 40% fat
Low Fat High Omega 3, Low Fat, High Fat
See Intervention Description
Low Fat diet
Low fat diet = 20% fat
Low Fat high n3 diet
Low Fat high n3 diet = 20% fat + 3% n3
High Fat Diet
High Fat Diet = 40% fat
Interventions
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Low Fat diet
Low fat diet = 20% fat
Low Fat high n3 diet
Low Fat high n3 diet = 20% fat + 3% n3
High Fat Diet
High Fat Diet = 40% fat
Eligibility Criteria
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Inclusion Criteria
* 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
* Known disease process, and 3) Use of prescription medications, including hormone replacement therapy.
40 Years
70 Years
FEMALE
Yes
Sponsors
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USDA Grand Forks Human Nutrition Research Center
FED
Responsible Party
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Principal Investigators
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Susan K Raatz, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
USDA, GFHNRC
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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McColley SP, Georgopoulos A, Young LR, Kurzer MS, Redmon JB, Raatz SK. A high-fat diet and the threonine-encoding allele (Thr54) polymorphism of fatty acid-binding protein 2 reduce plasma triglyceride-rich lipoproteins. Nutr Res. 2011 Jul;31(7):503-8. doi: 10.1016/j.nutres.2011.06.003.
Raatz SK, Young LR, Picklo MJ Sr, Sauter ER, Qin W, Kurzer MS. Total dietary fat and fatty acid content modifies plasma phospholipid fatty acids, desaturase activity indices, and urinary prostaglandin E in women. Nutr Res. 2012 Jan;32(1):1-7. doi: 10.1016/j.nutres.2011.12.006.
Young LR, Raatz SK, Thomas W, Redmon JB, Kurzer MS. Total dietary fat and omega-3 fatty acids have modest effects on urinary sex hormones in postmenopausal women. Nutr Metab (Lond). 2013 Apr 23;10(1):36. doi: 10.1186/1743-7075-10-36.
Young LR, Kurzer MS, Thomas W, Redmon JB, Raatz SK. Effect of dietary fat and omega-3 fatty acids on urinary eicosanoids and sex hormone concentrations in postmenopausal women: a randomized controlled feeding trial. Nutr Cancer. 2011;63(6):930-9. doi: 10.1080/01635581.2011.589957. Epub 2011 Jul 11.
Other Identifiers
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UMN914
Identifier Type: -
Identifier Source: org_study_id
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