Clinical Trial: Effect of Walnuts on Sperm Parameters and Male Fertility

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Walnuts on Sperm Parameters and Male Fertility

Brief Summary: The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men seeking care for infertility will beneficially affect sperm parameters and fertility. The investigators will compare the walnut intervention to the commonly suggested recommendation of adding an OTC multivitamin supplement to the diet.

Detailed Summary:

Purpose: The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men with oligo- astheno- or teratospermia will beneficially affect sperm parameters. The investigators found in a previous study (Robbins et al. 2012, Biology of Reproduction 87(4):101, 1-8.) that walnuts added to a Western diet improved sperm parameters in healthy, young men of unknown fertility and the most improvement occurred in participants with poor sperm parameters at baseline. The investigators now test the walnut dietary intervention in a fertility clinic population known to have poor sperm parameters. The investigators will compare the walnut intervention to the usual care suggestion of adding an OTC multivitamin supplement to the diet. Neither walnuts nor the OTC multivitamin have been tested for efficacy in this fertility clinic population previously.

Methods: A randomized, parallel two-group, dietary intervention trial with single-blind masking of outcome assessors will be conducted with up to 140 men who present for fertility work-up with semen parameters below the 25th centile for count, and 10th centile for motility and/or morphology according to the WHO 5th Edition, Laboratory Manual for the Processing and Examining of Human Semen, 2010. Repeated measures at baseline and 12 weeks include: semen analyses (primary outcome), blood fatty acid/ nutrient profiles (secondary outcomes); IPAQ physical activity questionnaire and IIEF index of erectile function (potential modifiers or confounders). Dietary intake will be assessed throughout using 24-hour ASA dietary recall x 5 and fertility assessed by questionnaire at one year post enrollment.

Sponsor: University of California, Los Angeles

Current Primary Outcome:

• Sperm count [ Time Frame: 12 weeks ]
  Change from baseline to three months in sperm count
• Sperm motility [ Time Frame: 12 weeks ]
  Change from baseline to 12 weeks in sperm motility
• Sperm morphology [ Time Frame: 12 weeks ]
  Change from baseline to 12 weeks in sperm morphology

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Fertility [ Time Frame: 12 months ]
  Fertilization of ova through natural conception or assisted reproductive technology
• Blood fatty acid and nutrient profile [ Time Frame: 12 weeks ]
  Change from baseline to 12 weeks in blood fatty acid profile and nutrients
• Sperm aneuploidy [ Time Frame: 12 weeks ]
  Change from baseline to 12 weeks in sperm aneuploidy
• Sperm DNA strand breakage [ Time Frame: 12 weeks ]
  Change from baseline to 12 weeks in sperm DNA integrity

Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: September 20, 2013
Date Started: May 2014
Date Completion: December 2017
Last Updated: November 22, 2016
Last Verified: November 2016