Effect of Walnuts on Sperm Parameters and Male Fertility

This study is not yet open for participant recruitment.
Verified September 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Wendie A Robbins, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01954498
First received: September 20, 2013
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Oligozoospermia
Asthenozoospermia
Teratozoospermia
Fertility
Dietary Supplement: Walnuts
Dietary Supplement: OTC multivitamin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Walnuts on Sperm Parameters and Male Fertility

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Sperm count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to three months in sperm count

  • Sperm motility [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 12 weeks in sperm motility

  • Sperm morphology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 12 weeks in sperm morphology


Secondary Outcome Measures:
  • Fertility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fertilization of ova through natural conception or assisted reproductive technology

  • Blood fatty acid and nutrient profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 12 weeks in blood fatty acid profile and nutrients

  • Sperm aneuploidy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 12 weeks in sperm aneuploidy

  • Sperm DNA strand breakage [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 12 weeks in sperm DNA integrity


Other Outcome Measures:
  • Physical Activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    IPAQ (International Physical Activity Questionnaire) assessment of change from baseline to 12 weeks

  • Sexual function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    IIEF (International Index of Erectile Function) assessment of change from baseline to 12 weeks

  • Dietary intake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    ASA-24 (Automated Self-administered) 24-hour dietary recalls x 5 over 12 weeks


Estimated Enrollment: 140
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Walnuts
2 ounces whole-shelled walnuts per day for 12 weeks
Dietary Supplement: Walnuts
Active Comparator: OTC (over-the-counter) multivitamin
OTC multivitamin tablet 2 per day for 12 weeks
Dietary Supplement: OTC multivitamin

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01954498

Contacts
Contact: Howard H Kim, MD 310-248-6970
Contact: Wendie A Robbins, RN, PhD 310-825-8999 wrobbins@sonnet.ucla.edu

Locations
United States, California
Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Howard H Kim, MD         
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Wendie A Robbins, RN, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Howard H Kim, MD Cedars-Sinai Medical Center, Los Angeles, CA
Principal Investigator: Wendie A Robbins, RN, PhD University of California, Los Angeles
  More Information

Publications:
Responsible Party: Wendie A Robbins, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01954498     History of Changes
Other Study ID Numbers: 20130929
Study First Received: September 20, 2013
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Randomized controlled trial
Spermatozoa
Sperm
Male Infertility
Walnuts
Nutrition
Male Reproduction

Additional relevant MeSH terms:
Oligospermia
Asthenozoospermia
Infertility, Male
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on April 20, 2014