Clinical trial NCT01954498: Effect of Walnuts on Sperm Parameters and Male Fertility
Official title: Effect of Walnuts on Sperm Parameters and Male Fertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligozoospermia
Asthenozoospermia
Teratozoospermia
Fertility
Keywords: Randomized controlled trial
Spermatozoa
Sperm
Male Infertility
Walnuts
Nutrition
Male Reproduction
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2013-10-01
Enrollment: 80
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sperm count
timeFrame: 12 weeks
measure: Sperm motility
timeFrame: 12 weeks
measure: Sperm morphology
timeFrame: 12 weeks
Secondary outcomes:
measure: Fertility
timeFrame: 12 months
measure: Blood fatty acid and nutrient profile
timeFrame: 12 weeks
measure: Sperm aneuploidy
timeFrame: 12 weeks
measure: Sperm DNA strand breakage
timeFrame: 12 weeks
Other outcomes:
measure: Physical Activity
timeFrame: 12 weeks
measure: Sexual function
timeFrame: 12 weeks
measure: Dietary intake
timeFrame: 12 weeks
Locations:
city: Los Angeles
country: United States
facility: Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center, Los Angeles, CA
name: Howard H Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Wendie A Robbins, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.