Effect of Walnuts on Sperm Parameters and Male Fertility
Ключові слова
Анотація
Опис
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.
Дати
| Востаннє перевірено: | 12/31/2019 |
| Перший поданий: | 09/19/2013 |
| Орієнтовна реєстрація подана: | 09/25/2013 |
| Опубліковано вперше: | 09/30/2013 |
| Останнє оновлення надіслано: | 01/23/2020 |
| Останнє оновлення опубліковано: | 01/27/2020 |
| Фактична дата початку навчання: | 04/30/2014 |
| Розрахункова дата первинного завершення: | 02/29/2020 |
| Розрахункова дата завершення дослідження: | 02/29/2020 |
Стан або захворювання
Втручання / лікування
Dietary Supplement: Walnuts
Dietary Supplement: OTC (over-the-counter) multivitamin
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| 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 (over-the-counter) multivitamin |
Критерії прийнятності
| Вік, придатний для навчання | 21 Years До 21 Years |
| Стать, яка підходить для вивчення | Male |
| Приймає здорових добровольців | Так |
| Критерії | 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 |
Результат
Заходи первинного результату
1. Sperm count [12 weeks]
2. Sperm motility [12 weeks]
3. Sperm morphology [12 weeks]
Заходи вторинного результату
1. Fertility [12 months]
2. Blood fatty acid and nutrient profile [12 weeks]
3. Sperm aneuploidy [12 weeks]
4. Sperm DNA strand breakage [12 weeks]
Інші результати діяльності
1. Physical Activity [12 weeks]
2. Sexual function [12 weeks]
3. Dietary intake [12 weeks]
