Effect of Walnuts on Sperm Parameters and Male Fertility
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Women's Studies |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/25/2018 |
| Start Date: | May 2014 |
| End Date: | December 2019 |
| Contact: | Howard H Kim, MD |
| Phone: | 310-248-6970 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Los Angeles, California 90095
310-825-4321
Principal Investigator: Wendie A Robbins, RN, PhD
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, California 90048
Principal Investigator: Howard H Kim, MD
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