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Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049309
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 23, 2017
National Cancer Institute (NCI)
Information provided by:
Duke University

Brief Summary:

RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease progression of prostate cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of a diet that is low in fat and/or high in flaxseed in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: dietary intervention Dietary Supplement: flaxseed Phase 2

Detailed Description:


  • Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat- and/or flaxseed-modified diets.
  • Compare differences in histopathological markers associated with prostate cancer (rates of apoptosis, extent of high-grade prostatic intraepithelial neoplasia) among patients in these diet groups.
  • Compare changes in serum prostate specific antigen among patients in these diet groups.
  • Compare changes in hormone-related factors (total serum testosterone and free androgen index, insulin-like growth factor [IGF], and IGF-binding protein-3) among patients in these diet groups.
  • Compare the effects of diet on nutritional biomarkers (levels of lignans in the urine and ejaculate, fatty acid profiles of erythrocytes and prostatic tissue) in these patients.
  • Determine associations between dietary modification and changes in dietary biomarkers, hormonal intermediates, and study endpoints in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to Gleason score (less than 7 vs at least 7) and race (black vs non-black). Patients are randomized to 1 of 4 diet groups.

  • Arm I (Flaxseed-supplemented diet): Patients are instructed to incorporate ground flaxseed into their daily diets.
  • Arm II (Low-fat diet): Patients are instructed on ways to achieve a diet with no greater than 20% of total energy from dietary fat.
  • Arm III (Flaxseed-supplemented, low-fat diet): Patients are instructed as in arm I and arm II.
  • Arm IV (Control diet): Patients are contacted weekly, but do not receive dietary counseling until after surgery.

All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery. After surgery, all patients receive dietary counseling.

PROJECTED ACCRUAL: A total of 160 patients (40 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets
Study Start Date : January 2003
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
No Intervention: Control
Usual diet
Experimental: Flaxseed diet
30 gram flaxseed dietary modification
Dietary Supplement: flaxseed
Experimental: Low fat diet
Low fat dietary modification
Dietary Supplement: dietary intervention
Experimental: Low fat + Flaxseed diet
Low fat and 30 gram flaxseed dietary modification
Dietary Supplement: dietary intervention
Dietary Supplement: flaxseed

Primary Outcome Measures :
  1. Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy

Secondary Outcome Measures :
  1. Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy
  2. Prostate-specific antigen by Hybritech assay at baseline and follow-up
  3. Total testosterone, sex hormone binding globulin, insulin-like growth factor (IGF), and IGF-binding protein-3, total cholesterol, and low-density lipoprotein cholesterol by ELISA assays at baseline and follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prostate cancer
  • At least 3 weeks until planned prostatectomy (24 days between day 1 visit and surgery)
  • Current diet that provides more than 30% of calories from fat



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Mentally competent
  • Able to speak and write English
  • Must have telephone access


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • No concurrent hormonal therapy


  • Not specified


  • At least 2 weeks since prior prostate biopsy


  • At least 7 days since prior antibiotics
  • No prior therapy for prostate cancer
  • No concurrent dietary supplements initiated within the past 3 months or anticipated to begin during study except standard multivitamin/mineral preparations (e.g., One-A-Day, Theragran, or Centrum) that do not supply > 100% of the recommended daily allowance of any vitamin or mineral
  • No other concurrent neoadjuvant therapies
  • No other concurrent flaxseed consumption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049309

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United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
Publications of Results:

Other Publications:
Layout table for additonal information Identifier: NCT00049309    
Other Study ID Numbers: Pro00008602
CDR0000258042 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2013
Keywords provided by Duke University:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases