Dietary Fat, Eicosanoids and Breast Cancer Risk

NCT01824498 | Completed Results

• 1 other identifier: UMN914
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer

Keywords

omega-3 fatty acids; sex hormones; urinary sex hormone metabolites

Outcome Measures

Primary Outcomes (2)

• Plasma Sex Hormone Levels

  8 weeks

• E2

  Estradiol

  8 weeks

Study Arms (6)

Low Fat, High Fat, Low Fat High Omega 3

EXPERIMENTAL

See Intervention Description

Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet

Low Fat, Low Fat High Omega 3, High Fat

EXPERIMENTAL

See Intervention Description

Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet

High Fat, Low Fat, Low Fat High Omega 3

EXPERIMENTAL

See Intervention Description

Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet

High Fat, Low fat High Omega 3, Low Fat

EXPERIMENTAL

See Intervention Description

Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet

Low Fat High Omega 3, High Fat, Low Fat

EXPERIMENTAL

See Intervention Description

Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet

Low Fat High Omega 3, Low Fat, High Fat

EXPERIMENTAL

See Intervention Description

Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet

Interventions

Low Fat diet OTHER

Low fat diet = 20% fat

High Fat, Low Fat, Low Fat High Omega 3; High Fat, Low fat High Omega 3, Low Fat; Low Fat High Omega 3, High Fat, Low Fat; Low Fat High Omega 3, Low Fat, High Fat; Low Fat, High Fat, Low Fat High Omega 3; Low Fat, Low Fat High Omega 3, High Fat

Low Fat high n3 diet OTHER

Low Fat high n3 diet = 20% fat + 3% n3

High Fat, Low Fat, Low Fat High Omega 3; High Fat, Low fat High Omega 3, Low Fat; Low Fat High Omega 3, High Fat, Low Fat; Low Fat High Omega 3, Low Fat, High Fat; Low Fat, High Fat, Low Fat High Omega 3; Low Fat, Low Fat High Omega 3, High Fat

High Fat Diet OTHER

High Fat Diet = 40% fat

High Fat, Low Fat, Low Fat High Omega 3; High Fat, Low fat High Omega 3, Low Fat; Low Fat High Omega 3, High Fat, Low Fat; Low Fat High Omega 3, Low Fat, High Fat; Low Fat, High Fat, Low Fat High Omega 3; Low Fat, Low Fat High Omega 3, High Fat

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women
• 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.

You may not qualify if:

• Smoking
• Known disease process, and 3) Use of prescription medications, including hormone replacement therapy.

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (4)

• 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.

  PMID: 21840466 BACKGROUND

• 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.

  PMID: 22260857 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.

  PMID: 23618064 BACKGROUND

• 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.

  PMID: 21745038 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Fat-Restricted; Diet, High-Fat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Susan Raatz, PhD, RD
• Organization: USDA, GFHNRC

susan.raatz@ars.usda.gov

701-795-8294

Study Officials

• Susan K Raatz, PhD, RD

  USDA, GFHNRC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: January 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2010
• Last Updated: August 31, 2018
• Results First Posted: September 25, 2013

Record last verified: 2018-08

Locations

US (1)