Effect of Walnuts on Sperm Parameters and Male Fertility

Fertility Clinical Trial

Official title:

Effect of Walnuts on Sperm Parameters and Male Fertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954498
• Other study ID #: 20130929
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 2020

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Asthenozoospermia
• Fertility
• Oligospermia
• Oligozoospermia
• Teratozoospermia

Intervention

Dietary Supplement:
• Walnuts

• OTC multivitamin

Locations

Country	Name	City	State
United States	Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Robbins WA, Xun L, FitzGerald LZ, Esguerra S, Henning SM, Carpenter CL. Walnuts improve semen quality in men consuming a Western-style diet: randomized control dietary intervention trial. Biol Reprod. 2012 Oct 25;87(4):101. doi: 10.1095/biolreprod.112.101634. Print 2012 Oct. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity	IPAQ (International Physical Activity Questionnaire) assessment of change from baseline to 12 weeks	12 weeks
Other	Sexual function	IIEF (International Index of Erectile Function) assessment of change from baseline to 12 weeks	12 weeks
Other	Dietary intake	ASA-24 (Automated Self-administered) 24-hour dietary recalls x 5 over 12 weeks	12 weeks
Primary	Sperm count	Change from baseline to three months in sperm count	12 weeks
Primary	Sperm motility	Change from baseline to 12 weeks in sperm motility	12 weeks
Primary	Sperm morphology	Change from baseline to 12 weeks in sperm morphology	12 weeks
Secondary	Fertility	Fertilization of ova through natural conception or assisted reproductive technology	12 months
Secondary	Blood fatty acid and nutrient profile	Change from baseline to 12 weeks in blood fatty acid profile and nutrients	12 weeks
Secondary	Sperm aneuploidy	Change from baseline to 12 weeks in sperm aneuploidy	12 weeks
Secondary	Sperm DNA strand breakage	Change from baseline to 12 weeks in sperm DNA integrity	12 weeks