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ALA and 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: NCT00309439
Recruitment Status : Unknown
Verified June 2012 by David Jenkins, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2006
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
David Jenkins, University of Toronto

Brief Summary:
The problem is the lack of data from randomized controlled trials to throw light on the ALA-prostate cancer issue. There is therefore a need to acquire evidence from a randomized controlled study to illustrate the effect of ALA on a surrogate marker for prostate cancer, namely prostate specific antigen (PSA). Demonstration that atrial fibrillation recurrence was reduced after cardioversion and that there was no adverse effect of 1 years of ALA feeding on PSA would go a considerable way to providing the required evidence that ALA in the human diet has no adverse effect on the prostate and so allow its use for cardiovascular risk reduction. hypothesis: The effect of ALA on PSA levels over time will be no different from the control, so providing supportive data for the view that ALA is not cancer promoting.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diet Therapy Prostate Cancer Procedure: ALA-rich diet Phase 2

Detailed Description:

In addition disturbing news on alpha-linolenic acid (ALA) has recently been reviewed by Brouwer and colleagues (J Nutr:2004). Their analyses suggests that ALA, as found in canola oil and other healthy foods, may cause prostate cancer even though there is good evidence that canola oil will prevent heart disease. This issue urgently needs further research.

In studies largely from the Harvard group, but suggested by additional studies from Uruguay and Spain, a link has been identified between ALA intake and prostate cancer. The Harvard studies are cohort studies where groups of approximately 40,000 doctors or health professionals have been followed up for periods of 10 years and the dietary intakes of ALA related to the subsequent development of aggressive prostate cancer. It must be stressed that these are not randomized crossover studies which are the currently accepted gold standard for evidence-based medicine and regulatory decision making. Nevertheless they raise concern over the health profile of a fatty acid with a growing reputation for cardiovascular disease prevention and a component of other healthy foods such as walnuts, flax, canola and soy.

The same Harvard group identified the deleterious effects on cardiovascular health of trans fatty acids in their cohort studies and this has resulted in a major effort to remove trans fatty acids from the food supply. On the other hand their identification of the benefits of vitamin E in their cohort studies has not been confirmed by subsequent randomized controlled trials. Although Dr Willett, the senior member of the Harvard group, has drawn surprisingly little attention to the negative findings with ALA, it remains a sticking point with regulators in the current debate over the inclusion and use of ALA in the food supply. This concern has been sufficient for the Natural Health Products Directorate of Health Canada to ask for a full proposal from us before we start studies on ALA in the prevention of atrial fibrillation due the apparently negative impact of ALA consumption on prostate cancer.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Studies of Serum PSA to Help Resolve the Current Implication of Alpha-linolenic Acid (ALA) and Prostate Cancer

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Blood samples available from Bordeaux

Exclusion Criteria:

  • Blood samples not received from Bordeaux

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): NCT00309439

Sponsors and Collaborators
University of Toronto
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Principal Investigator: David JA Jenkins University of Toronto

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Responsible Party: David Jenkins, Principle Investigator, University of Toronto Identifier: NCT00309439     History of Changes
Other Study ID Numbers: REB15636
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
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Prostatic Neoplasms
Atrial Fibrillation
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes