Effects of a Fasting Mimicking Diet on Sperm Quality
- Conditions
- Sperm Count, LowFertility DisordersSub Fertility, Male
- Interventions
- Behavioral: Fasting Mimicking Diet
- Registration Number
- NCT04908774
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
This study investigates the effect of repetitive cycles of a Fasting Mimicking Diet (3x5 days in six months) on sperm quality in men
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fasting Mimicking Diet Group Fasting Mimicking Diet The intervention group follows a fasting mimicking diet for 5 days every 6-8 weeks (a total of 3 times in 5 months).
- Primary Outcome Measures
Name Time Method Change in Total sperm motility change from baseline to 6 months after baseline WHO-5 spermiogram parameter to measure sperm quality
Qualitative interview analysis up to 48 weeks after fasting intervention individual and focus group interviews
- Secondary Outcome Measures
Name Time Method 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 validated questionnaire to examine gratitude
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 ASKU, validated questionnaire to examine self-efficacy. The ASKU with three items is used for the economic measurement of subjective competence expectations. It includes the psychological variables self-esteem, internal locus of control, global life satisfaction, optimism as well as the personality traits neuroticism and extraversion from the five-factor model
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 WHO-5 questionnaire, validated questionnaire to evaluate the quality of life. It includes 5 questions that assess feelings or moods over the past two weeks. The items in this questionnaire are scaled on a six-point scale. The 5 items result in a total score from a minimum of zero to a maximum of 25, whereby a total score of less than 13 or a score of zero as an answer to one of the questions indicates a possible depression.
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 questionnaire to examine the relationship between the two partners desiring to have a child
spermiogram following the WHO-5 criteria baseline and approx. every 2 months over the course of a year (12 months) WHO-5 measurement of sperm quality
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 MAAS-questionnaire, validated questionnaire to examine mindfulness. It consists of 14 items with four-point Likert scales (never, almost never, sometimes, often, very often). A sum score is formed by adding them up.
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 HADS-questionnaire, validated questionnaire to examine anxiety and depression. The HADS-D is used to assess anxiety and depression in patients with physical diseases or (possibly psychogenic) physical complaints. It measures the degree of anxiety and depressive symptoms during the past week by means of self-report, which is recorded on two subscales with seven items each. The total score can be used as a measure of general psychological impairment.
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 questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
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 Cohen-stress scale, validated questionnaire to examine experienced stress. Cohen Perceived Stress Scale (CPSS): The CPSS measures the degree of acute subjective experience of stress (Cohen 1983). It consists of 14 items with four-point Likert scales (never, almost never, sometimes, often, very often). A sum score is formed by summing up the items.
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 questionnaire to examine physical fitness
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 ASTS-questionnaire, validated questionnaire to examine current mood.The "Profile of Mood States" served as the basis for the contruction. The ASTS comprises 19 items on five subscales: sadness, hopelessness, fatigue, anger and positive mood.
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 questionnaire to examine diet
Trial Locations
- Locations (1)
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
🇩🇪Berlin, Germany