An interventional study of Fasting Mimicking Diet in Sub Fertility, Male, Fertility Disorders and Sperm Count, Low, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
This study investigates the effect of repetitive cycles of a Fasting Mimicking Diet (3x5 days in six months) on sperm quality in men
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's enrollment of 22 is below the median of 65 across 46 interventional studies indexed under Oligospermia.
Browse Oligospermia studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Compared within Oligospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility, Male. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group follows a fasting mimicking diet for 5 days every 6-8 weeks (a total of 3 times in 5 months).
Behavioral: Fasting Mimicking Diet
This group maintains their individual diet during the whole time of the study. After 6 months they are offered a fasting intervention.
The mobile application "Salufast" provides standardised fasting packages for 5 days of approx. 500 kcal and accompanies the participants during all fasting days.
Also known as: Fasting, Dietary Intervention
Change in Total sperm motility
WHO-5 spermiogram parameter to measure sperm quality
Time frame: change from baseline to 6 months after baseline
Qualitative interview analysis
individual and focus group interviews
Time frame: up to 48 weeks after fasting intervention
spermiogram following the WHO-5 criteria
WHO-5 measurement of sperm quality
Time frame: baseline and approx. every 2 months over the course of a year (12 months)
quality of life according to the WHO-Five Well-Being Index
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.
Time frame: 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
mindfulness
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
questionnaire to examine physical fitness
Time frame: 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
questionnaire to examine diet
Time frame: 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
questionnaire to examine the relationship between the two partners desiring to have a child
Time frame: 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
questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
Time frame: 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
gratitude
validated questionnaire to examine gratitude
Time frame: 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
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
Time frame: 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
liver sonography
sonography in a subgroup
Time frame: up to 14 days before, during and up to 14 days after a fasting intervention
reported pregnancy of female partner
questionnaire
Time frame: up to 12 months after baseline
Plan to share: Yes — Data will be made available upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: after the end of the study for 5 years
Access criteria: on demand
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →