Benefits of Walnuts for Male Reproductive Health
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- change from baseline in semen quality at 12 weeks
研究概览
简要总结
Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other nutrients essential to sperm development and function. This randomized controlled trial sought to determine if a Western style diet supplemented with walnuts would improve sperm quality as a predictor of male fertility.
详细描述
A vast research base on human sperm shows the following to be critical for normal sperm development and function: Polyunsaturated fatty acids provide fluidity to sperm membranes allowing sperm to swim, fuse with ova, and support key cellular functions. Antioxidants protect sperm from reactive oxygen species generated during normal physiologic processes or white blood cells that infiltrate into seminal fluid and injure membranes and fragment sperm DNA. Selenium is critical in the form of anti-oxidant selenoproteins protecting developing sperm in the testes and later selenium in the epididymis participates in cell shape for motility. Folate, in a recent study, was associated with decreased aneuploidy (abnormal number of chromosomes)in sperm. Deficiency in any of these factors - lipids, antioxidants, selenium, or folate could manifest as poor semen quality and sub-fertility.
Walnuts provide a rich dietary source of each of the critical factors discussed above. Walnuts contain beneficial lipids, antioxidants, selenium, and folate. Walnuts, as a natural whole food source, may be preferential to commercial supplements and, as a plant source of nutrients, leave a positive green footprint on the planet.
Hypothesis The investigators hypothesize that diets enriched in walnuts will improve semen quality. Semen quality is a predictive marker for male infertility and sub-fertility, thus, the overall goal is to determine if dietary intake of walnuts will benefit male reproductive health.
A randomized, controlled intervention will be used to study the effects of walnut supplementation on semen quality measures in young men (ages 21 to 35) eating Western diets. Participants will be enrolled from the West Los Angeles area (n=120). Men will be randomly assigned to consume 3 oz of walnuts per day as part of their usual diet or to continue their habitual diet but avoid nuts. Each will follow the assigned diet for three months to cover one complete cycle of spermatogenesis.
The specific aims of the study are to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 21 to 35 years
- •Residence is in West Los Angeles for the next three months
- •Free from chronic diseases requiring medications
- •Free from nut allergies or nut intolerance
- •Not taking anti-oxidant supplements
排除标准
- •Outside the age range of 21 to 35 years
- •Residence outside West Los Angeles area prohibiting two trips to the clinical research laboratory
- •Current smoker
- •Taking medications for chronic disease
- •Nut allergies or nut intolerance
- •Taking anti-oxidant supplements -
结局指标
主要结局
change from baseline in semen quality at 12 weeks
时间窗: change from baseline at 12 weeks
semen quality is measured as sperm count, motility, vitality, morphology, DNA integrity
change from baseline in serum fatty acids at 12 weeks
时间窗: change from baseline at 12 weeks
change from baseline in serum zinc at 12 weeks
时间窗: change from baseline at 12 weeks
change from baseline in serum folate at 12 weeks
时间窗: change from baseline at 12 weeks
change from baseline in serum selenium at 12 weeks
时间窗: change from baseline at 12 weeks
次要结局
- change from baseline in body weight pounds at 12 weeks(change from baseline at 12 weeks)
- change from baseline in nutrient intake at 12 weeks(change from baseline at 12 weeks)