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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. 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
The guiding concept of our proposal is that both the total fat and the fatty acid composition of the diet contribute to a milieu associated with the risk for sex-hormone mediated cancers. 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. When compared with the high fat diet, we expect n3 concentrations to increase and sex hormone levels to decrease after both low fat and low fat/n3 rich diets, with the greatest response in the low fat-n3 supplemented group. The aims of this project are: 1) to evaluate the effects of total fat and n3 fatty acid consumption on plasma and urine sex hormone concentrations in postmenopausal women, 2) to evaluate the relationship between plasma concentrations of fatty acids and plasma and urinary sex hormone concentrations, and 3) to evaluate the effects of total fat and n3 fatty acid consumption on the associations between sex hormone concentrations and urinary prostaglandin E2 and thromboxane B2 concentrations.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Fat, High Fat, Low Fat High Omega 3 | Experimental | See Intervention Description |
|
| Low Fat, Low Fat High Omega 3, High Fat | Experimental | See Intervention Description |
|
| High Fat, Low Fat, Low Fat High Omega 3 | Experimental | See Intervention Description |
|
| High Fat, Low fat High Omega 3, Low Fat | Experimental | See Intervention Description |
|
| Low Fat High Omega 3, High Fat, Low Fat | Experimental | See Intervention Description |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Fat diet | Other | Low fat diet = 20% fat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Sex Hormone Levels | 8 weeks | |
| E2 | Estradiol | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan K Raatz, PhD, RD | USDA, GFHNRC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21840466 | Background | 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. | |
| 22260857 | Background |
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Subjects enrolled prior to randomization (N=18)
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Fat, High Fat, Low Fat High Omega 3 | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| FG001 | Low Fat, Low Fat High Omega 3, High Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| FG002 | High Fat, Low Fat, Low Fat High Omega 3 | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| FG003 | High Fat, Low Fat High Omega 3, Low Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| FG004 | Low Fat High Omega 3, High Fat, Low Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| FG005 | Low Fat High Omega 3, Low Fat, High Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Intervention (8 Weeks) |
| |||||||||||||
| Washout (8 Weeks) |
| |||||||||||||
| 2nd Intervention (8 Weeks) |
| |||||||||||||
| Washout (8 Weeks) |
| |||||||||||||
| 3rd Intervention (8 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Fat, High Fat, Low Fat High Omega 3 | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| BG001 | Low Fat, Low Fat High Omega 3, High Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Sex Hormone Levels | Not Posted | 8 weeks | Participants | ||||||||||||
| Primary | E2 | Estradiol | Posted | Least Squares Mean | Standard Error | pmol/L | 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Fat Diet | High fat diet = 40% fat |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Raatz, PhD, RD | USDA, GFHNRC | 701-795-8294 | susan.raatz@ars.usda.gov |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D059305 | Diet, High-Fat |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low Fat High Omega 3, Low Fat, High Fat |
| Experimental |
See Intervention Description |
|
| Low Fat high n3 diet | Other | Low Fat high n3 diet = 20% fat + 3% n3 |
|
| High Fat Diet | Other | High Fat Diet = 40% fat |
|
| 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. |
| 23618064 | Background | 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. |
| 21745038 | Result | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | High Fat, Low Fat, Low Fat High Omega 3 | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| BG003 | High Fat, Low Fat High Omega 3, Low Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| BG004 | Low Fat High Omega 3, High Fat, Low Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| BG005 | Low Fat High Omega 3, Low Fat, High Fat | Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | High Fat Diet | Hig fat diet = 40% fat |
| OG001 | Low Fat Diet | Low fat diet = 20% fat |
| OG002 | Low Fat, High n3 Diet | Low fat, n3 diet = 20% fat + 3% n3 |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Low Fat Diet | Low fat diet = 20% fat | 0 | 18 | 0 | 18 |
| EG002 | Low Fat, High n3 Diet | Low fat, high n3 diet = 20% fat + 3% n3 | 0 | 18 | 0 | 18 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |