Effects of Repetitive Cycles of a Fasting Mimicking Diet on Sperm Quality in Men Between 18 and 60 With Reduced Sperm Quality According to the WHO-5 Criteria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Total sperm motility
研究概览
简要总结
This study investigates the effect of repetitive cycles of a Fasting Mimicking Diet (3x5 days in six months) on sperm quality in men
详细描述
This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in male infertility due to reduced sperm quality according to WHO5-criteria. The participants will be randomized in two groups. The intervention group follows a regime of a periodic fasting mimicking diet (3x5 days in six months, every 6-8 weeks, accompanied via a mobile application), whereas the patients on the waiting list continue their normal diet. Spermiograms are taken about every 2 months following the WHO-5 criteria. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.
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)
盲法说明
It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged between 18 and 60 years
- •Unfulfilled desire to have a child > 1 year
- •reduced sperm quality (proven via spermiogram according tho WHO-5 criteria)
- •informed consent
- •20 kg/m² <= BMI <= 35 kg/m²
排除标准
- •No sufficient communication possible
- •severely impairing cognitive illness
- •serious mental illness
- •Patients with anatomical/organic damage of reproductive organs
- •Eating disorders in the medical history
- •Serious internal diseases
- •Lack of internet access
- •No consent to randomisation
- •Participation in other studies
结局指标
主要结局
Change in Total sperm motility
时间窗: change from baseline to 6 months after baseline
WHO-5 spermiogram parameter to measure sperm quality
Qualitative interview analysis
时间窗: up to 48 weeks after fasting intervention
individual and focus group interviews
次要结局
- gratitude(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- self-efficacy(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- quality of life according to the WHO-Five Well-Being Index(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- quality of relationship(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- spermiogram following the WHO-5 criteria(baseline and approx. every 2 months over the course of a year (12 months))
- mindfulness(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- anxiety and depression(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- psychological stress caused by the unfulfilled desire to have children(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- experienced stress(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- physical fitness(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- current mood(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
- Changes in diet(baseline, after one week, after 8 (±2) weeks, after 12 (±2) weeks, after 17 (±2) weeks, after 26 (±2) weeks and after 52 (±2) weeks)
研究者
Andreas Michalsen
Prof. Dr. med.
Charite University, Berlin, Germany