Effect of Walnuts on Sperm Parameters and Male Fertility
Primary Purpose
Oligozoospermia, Asthenozoospermia, Teratozoospermia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walnuts
OTC multivitamin
Sponsored by
About this trial
This is an interventional treatment trial for Oligozoospermia focused on measuring Randomized controlled trial, Spermatozoa, Sperm, Male Infertility, Walnuts, Nutrition, Male Reproduction
Eligibility 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
Sites / Locations
- Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center
- University of California Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Walnuts
OTC (over-the-counter) multivitamin
Arm Description
2 ounces whole-shelled walnuts per day for 12 weeks
OTC multivitamin tablet 2 per day for 12 weeks
Outcomes
Primary Outcome Measures
Sperm count
Change from baseline to three months in sperm count
Sperm motility
Change from baseline to 12 weeks in sperm motility
Sperm morphology
Change from baseline to 12 weeks in sperm morphology
Secondary Outcome Measures
Fertility
Fertilization of ova through natural conception or assisted reproductive technology
Blood fatty acid and nutrient profile
Change from baseline to 12 weeks in blood fatty acid profile and nutrients
Sperm aneuploidy
Change from baseline to 12 weeks in sperm aneuploidy
Sperm DNA strand breakage
Change from baseline to 12 weeks in sperm DNA integrity
Full Information
NCT ID
NCT01954498
First Posted
September 20, 2013
Last Updated
November 30, 2020
Sponsor
University of California, Los Angeles
Collaborators
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01954498
Brief Title
Effect of Walnuts on Sperm Parameters and Male Fertility
Official Title
Effect of Walnuts on Sperm Parameters and Male Fertility
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligozoospermia, Asthenozoospermia, Teratozoospermia, Fertility
Keywords
Randomized controlled trial, Spermatozoa, Sperm, Male Infertility, Walnuts, Nutrition, Male Reproduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walnuts
Arm Type
Experimental
Arm Description
2 ounces whole-shelled walnuts per day for 12 weeks
Arm Title
OTC (over-the-counter) multivitamin
Arm Type
Active Comparator
Arm Description
OTC multivitamin tablet 2 per day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Walnuts
Intervention Type
Dietary Supplement
Intervention Name(s)
OTC multivitamin
Primary Outcome Measure Information:
Title
Sperm count
Description
Change from baseline to three months in sperm count
Time Frame
12 weeks
Title
Sperm motility
Description
Change from baseline to 12 weeks in sperm motility
Time Frame
12 weeks
Title
Sperm morphology
Description
Change from baseline to 12 weeks in sperm morphology
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fertility
Description
Fertilization of ova through natural conception or assisted reproductive technology
Time Frame
12 months
Title
Blood fatty acid and nutrient profile
Description
Change from baseline to 12 weeks in blood fatty acid profile and nutrients
Time Frame
12 weeks
Title
Sperm aneuploidy
Description
Change from baseline to 12 weeks in sperm aneuploidy
Time Frame
12 weeks
Title
Sperm DNA strand breakage
Description
Change from baseline to 12 weeks in sperm DNA integrity
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Physical Activity
Description
IPAQ (International Physical Activity Questionnaire) assessment of change from baseline to 12 weeks
Time Frame
12 weeks
Title
Sexual function
Description
IIEF (International Index of Erectile Function) assessment of change from baseline to 12 weeks
Time Frame
12 weeks
Title
Dietary intake
Description
ASA-24 (Automated Self-administered) 24-hour dietary recalls x 5 over 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard H Kim, MD
Organizational Affiliation
Cedars-Sinai Medical Center, Los Angeles, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wendie A Robbins, RN, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22895856
Citation
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.
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Effect of Walnuts on Sperm Parameters and Male Fertility
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