7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- sperm motility
研究概览
简要总结
Setting. Outpatient fertility clinic.
Aim. Investigate if a modification in nutritional habits may improve in the short term the qualities of human sperm, testing two hypothesis:
i) that adding to the diet a natural whole food rich in polyunsaturated fatty acids (PUFA)
OR
ii) that reducing the intake of saturated fatty acids and increasing the consumption of PUFA may affect beneficially sperm parameters.
Population. N. 100 hypofertile male subjects attending a fertility clinic.
Type of study. Interventional study. No drugs or pharmacologic supplementation will be required nor allowed.
Two different type of intervention are scheduled:
- Supplementation to western style diet with nuts, naturally rich in PUFA
- Diet modification increasing intake of PUFA-rich foods and cutting the consumption of food rich in saturated fats.
Protocol
- Baseline visit and recruiting.
- Informed consent
- Randomized allocation to treatment group in a 1: 1 manner
Blinding. Investigators deputed to sperm analysis and statistician are blinded as to type of intervention.
Phases:
- i) basal
- ii) after 15 weeks That interval is chosen because encompasses an entire spermatogenesis cycle.
Outcomes. Primary
- sperm count, concentration,morphology and mobility.
Secondary:
- serum folate assay,
- plasma PUFA (ALA, EPA, DHA) assay,
- body weight and BMI variation
Statistics. A comparison for all sperm parameters (count,concentration,morphologic abnormalities, mobility) will be carried out by an analysis within groups and within patient.
详细描述
The planned trial is nutritional based only, with a modification of diet in order to obtain an increase of PUFA intake with/without a reduction of saturated fatty acid intake.
Two different types of intervention are scheduled:
- Supplementation to western style diet with food naturally rich in PUFA
- Diet modification, increasing intake of PUFA naturally rich foods and cutting the consumption of saturated fats.
The supplementation is obtained adding 7 nuts a day to regular diet. The diet modification is obtained by increasing intake of nuts and seeds (walnuts, hazelnuts, almonds, peanuts, sesame, sunflower, flaxseed) and derived oils, fish and vegetables; cutting the consumption of processed meat and dairy products is required as well.
The type of diet or supplementation is supported by oral and written information. The compliance to diet will be followed by administration of validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •sperm concentration > 5.000.000 ml
- •progressive motile forms < 35%
- •BMI < 30
- •normal FSH (Follicle Stimulating Hormone reference values 1-10 IU)
排除标准
- •allergy to nuts or seeds
- •clinical varicocele
- •recent surgery for varicocele
- •vasectomy
结局指标
主要结局
sperm motility
时间窗: 15 weeks
change in sperm motility (% of progressive forms) from baseline to 15 weeks
sperm count
时间窗: 15 weeks
Change in sperm count from baseline to 15 weeks
sperm concentration
时间窗: 15 weeks
change in sperm concentration from baseline to 15 weeks
sperm morphology
时间窗: 15 weeks
change in sperm morphology ( % normal forms ) from baseline to 15 weeks
次要结局
- change in weight (BMI)(15 weeks)
- Change in serum cholesterol(15 weeks)
- change in serum folate(15 weeks)
- change in plasma alpha linolenic acid (ALA) levels(15 weeks)
- change in plasma eicosapentaenoic acid (EPA)(15 weeks)
- change in plasma docosahexaenoic acid (DHA)(15 weeks)
研究者
Aldo Maina
MD Internal Medicine Obstetric Medicine
A.O.U. Città della Salute e della Scienza