Clinical trial NCT04908774: Effects of a Fasting Mimicking Diet on Sperm Quality
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sub Fertility, Male
Fertility Disorders
Sperm Count, Low
Keywords: fasting
natural therapies
fasting mimicking diet
caloric restriction
dietary restriction
dietary intervention
lifestyle modification
spermiogram
sperm motility
liquefaction time
sperm morphology
total sperm count
sperm density
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2021-06-01
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This explorative study is conducted in form of a randomized, controlled trial design with a fasting intervention and a waiting list, which continues the usual diet.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Total sperm motility
timeFrame: change from baseline to 6 months after baseline
measure: Qualitative interview analysis
timeFrame: up to 48 weeks after fasting intervention
Secondary outcomes:
measure: spermiogram following the WHO-5 criteria
timeFrame: baseline and approx. every 2 months over the course of a year (12 months)
measure: quality of life according to the WHO-Five Well-Being Index
timeFrame: 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
measure: mindfulness
timeFrame: 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
measure: anxiety and depression
timeFrame: 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
measure: current mood
timeFrame: 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
measure: experienced stress
timeFrame: 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
measure: physical fitness
timeFrame: 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
measure: Changes in diet
timeFrame: 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
measure: quality of relationship
timeFrame: 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
measure: psychological stress caused by the unfulfilled desire to have children
timeFrame: 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
measure: gratitude
timeFrame: 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
measure: self-efficacy
timeFrame: 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
Other outcomes:
measure: liver sonography
timeFrame: up to 14 days before, during and up to 14 days after a fasting intervention
measure: reported pregnancy of female partner
timeFrame: up to 12 months after baseline
Locations:
city: Berlin
country: Germany
facility: Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: