Clinical Trials Directory

Trials / Completed

CompletedNCT01954498

Effect of Walnuts on Sperm Parameters and Male Fertility

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
Male
Age
21 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTWalnuts
DIETARY_SUPPLEMENTOTC multivitamin

Timeline

Start date
2014-05-01
Primary completion
2020-03-01
Completion
2020-03-01
First posted
2013-10-01
Last updated
2026-03-13

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01954498. Inclusion in this directory is not an endorsement.