NCT01954498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 13, 2026

Status Verified

November 1, 2020

Enrollment Period

5.8 years

First QC Date

September 20, 2013

Last Update Submit

March 11, 2026

Conditions

AsthenozoospermiaOligozoospermiaTeratozoospermiaFertility

Keywords

Randomized controlled trialSpermatozoaSpermMale InfertilityWalnutsNutritionMale Reproduction

Outcome Measures

Primary Outcomes (3)

  • Sperm count

    Change from baseline to three months in sperm count

    12 weeks

  • Sperm motility

    Change from baseline to 12 weeks in sperm motility

    12 weeks

  • Sperm morphology

    Change from baseline to 12 weeks in sperm morphology

    12 weeks

Secondary Outcomes (4)

  • Fertility

    12 months

  • Blood fatty acid and nutrient profile

    12 weeks

  • Sperm aneuploidy

    12 weeks

  • Sperm DNA strand breakage

    12 weeks

Other Outcomes (3)

  • Physical Activity

    12 weeks

  • Sexual function

    12 weeks

  • Dietary intake

    12 weeks

Study Arms (2)

Walnuts

EXPERIMENTAL

2 ounces whole-shelled walnuts per day for 12 weeks

Dietary Supplement: Walnuts

OTC (over-the-counter) multivitamin

ACTIVE COMPARATOR

OTC multivitamin tablet 2 per day for 12 weeks

Dietary Supplement: OTC multivitamin

Interventions

WalnutsDIETARY_SUPPLEMENT
Walnuts
OTC multivitaminDIETARY_SUPPLEMENT
OTC (over-the-counter) multivitamin

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Related 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.

    PMID: 22895856BACKGROUND

MeSH Terms

Conditions

OligospermiaAsthenozoospermiaTeratozoospermiaInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Howard H Kim, MD

    Cedars-Sinai Medical Center, Los Angeles, CA

    PRINCIPAL INVESTIGATOR

  • Wendie A Robbins, RN, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

October 1, 2013

Study Start

May 1, 2014

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 13, 2026

Record last verified: 2020-11

Locations

US(2)