Benefits of Walnuts for Male Reproductive Health

This study has been completed.
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Wendie A Robbins, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01505140
First received: December 31, 2011
Last updated: January 3, 2012
Last verified: January 2012

December 31, 2011
January 3, 2012
November 2009
December 2010   (final data collection date for primary outcome measure)
  • change from baseline in semen quality at 12 weeks [ Time Frame: change from baseline at 12 weeks ] [ Designated as safety issue: No ]
    semen quality is measured as sperm count, motility, vitality, morphology, DNA integrity
  • change from baseline in serum fatty acids at 12 weeks [ Time Frame: change from baseline at 12 weeks ] [ Designated as safety issue: No ]
  • change from baseline in serum selenium at 12 weeks [ Time Frame: change from baseline at 12 weeks ] [ Designated as safety issue: No ]
  • change from baseline in serum folate at 12 weeks [ Time Frame: change from baseline at 12 weeks ] [ Designated as safety issue: No ]
  • change from baseline in serum zinc at 12 weeks [ Time Frame: change from baseline at 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01505140 on ClinicalTrials.gov Archive Site
  • change from baseline in body weight pounds at 12 weeks [ Time Frame: change from baseline at 12 weeks ] [ Designated as safety issue: No ]
  • change from baseline in nutrient intake at 12 weeks [ Time Frame: change from baseline at 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Benefits of Walnuts for Male Reproductive Health
Benefits of Walnuts for Male Reproductive Health

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Infertility
  • Nutrition Disorders
Other: Whole walnuts
75 gm whole walnuts per day will be consumed with usual Western style diet
  • No Intervention: Usual Western style diet
    Participants will consume their usual Western style diet avoiding tree nuts
  • Experimental: Whole walnuts
    Participants will consume usual Western style diet adding 75 gm whole walnuts per day
    Intervention: Other: Whole walnuts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria: Males

  1. Age 21 to 35 years
  2. Residence is in West Los Angeles for the next three months
  3. Non-smoker
  4. Free from chronic diseases requiring medications
  5. Free from nut allergies or nut intolerance
  6. Not taking anti-oxidant supplements

Exclusion Criteria:

  1. Outside the age range of 21 to 35 years
  2. Residence outside West Los Angeles area prohibiting two trips to the clinical research laboratory
  3. Current smoker
  4. Taking medications for chronic disease
  5. Nut allergies or nut intolerance
  6. Taking anti-oxidant supplements -
Male
21 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01505140
445246WR77518
No
Wendie A Robbins, University of California, Los Angeles
University of California, Los Angeles
California Walnut Commission
Principal Investigator: Wendie A Robbins, RN, PhD University of California, Los Angeles
University of California, Los Angeles
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP