Effect of Walnuts on Sperm Parameters and Male Fertility

Not Applicable

Completed

• Conditions: Teratozoospermia; Asthenozoospermia; Oligozoospermia; Fertility
• Interventions: Dietary Supplement: Walnuts; Dietary Supplement: OTC multivitamin

• Registration Number: NCT01954498
• Lead Sponsor: University of California, Los Angeles

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Study Start: 2014-05
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• Age 21 years or older
• Sperm concentration < or = to 41 million per ml
• Sperm motility < or = to 40%
• Normal sperm morphology forms < or = to 5.5%
• Patients of Howard H. Kim, MD seen at the Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center, Los Angeles, California
• Have eaten walnuts throughout life without adverse reaction

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Exclusion Criteria

• Allergy to walnuts or tree nuts
• Food allergy
• Known genetic cause of infertility
• Known anatomical cause of infertility
• History of seizure disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walnuts	Walnuts	2 ounces whole-shelled walnuts per day for 12 weeks
OTC (over-the-counter) multivitamin	OTC multivitamin	OTC multivitamin tablet 2 per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Sperm count	12 weeks	Change from baseline to three months in sperm count
Sperm motility	12 weeks	Change from baseline to 12 weeks in sperm motility
Sperm morphology	12 weeks	Change from baseline to 12 weeks in sperm morphology

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States