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Clinical Trial Summary

Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other nutrients essential to sperm development and function. This randomized controlled trial sought to determine if a Western style diet supplemented with walnuts would improve sperm quality as a predictor of male fertility.


Clinical Trial Description

A vast research base on human sperm shows the following to be critical for normal sperm development and function: Polyunsaturated fatty acids provide fluidity to sperm membranes allowing sperm to swim, fuse with ova, and support key cellular functions. Antioxidants protect sperm from reactive oxygen species generated during normal physiologic processes or white blood cells that infiltrate into seminal fluid and injure membranes and fragment sperm DNA. Selenium is critical in the form of anti-oxidant selenoproteins protecting developing sperm in the testes and later selenium in the epididymis participates in cell shape for motility. Folate, in a recent study, was associated with decreased aneuploidy (abnormal number of chromosomes)in sperm. Deficiency in any of these factors - lipids, antioxidants, selenium, or folate could manifest as poor semen quality and sub-fertility.

Walnuts provide a rich dietary source of each of the critical factors discussed above. Walnuts contain beneficial lipids, antioxidants, selenium, and folate. Walnuts, as a natural whole food source, may be preferential to commercial supplements and, as a plant source of nutrients, leave a positive green footprint on the planet.

Hypothesis The investigators hypothesize that diets enriched in walnuts will improve semen quality. Semen quality is a predictive marker for male infertility and sub-fertility, thus, the overall goal is to determine if dietary intake of walnuts will benefit male reproductive health.

A randomized, controlled intervention will be used to study the effects of walnut supplementation on semen quality measures in young men (ages 21 to 35) eating Western diets. Participants will be enrolled from the West Los Angeles area (n=120). Men will be randomly assigned to consume 3 oz of walnuts per day as part of their usual diet or to continue their habitual diet but avoid nuts. Each will follow the assigned diet for three months to cover one complete cycle of spermatogenesis.

The specific aims of the study are to:

1. Establish at baseline: habitual diet; serum omega-3 to omega-6 ratio, serum selenium and folate; semen quality (sperm count, motility, morphology) and sperm DNA integrity (COMET assay); sperm aneuploidy; and semen anti-oxidant levels

2. Randomly assign men to habitual diet plus 3 oz walnuts per day or usual diet without nuts for three months monitored by six telephone 24 hour dietary recalls

3. Compare intervention and control groups at three months on blood and semen measures

4. Compare blood and semen measures within man between baseline and three months. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01505140
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase Phase 2
Start date November 2009
Completion date December 2010

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