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AzTrials

Sub Fertility, MaleKiWu-BNCT04908774

Effects of a Fasting Mimicking Diet on Sperm Quality

A study testing Fasting Mimicking Diet in people with Sub Fertility, Male and Fertility Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the effect of repetitive cycles of a Fasting Mimicking Diet (3x5 days in six months) on sperm quality in men Read more about this study

Who is it for?
Ages 18 to 60 years, men only
What is being tested?
Fasting Mimicking Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteGermany
Study dates
25 May 2021to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Lack of internet access
  • No consent to randomisation
  • Participation in other studies

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

    Berlin, 14109

Other trials in Germany

About this study

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.

This study investigates the effect of repetitive cycles of a Fasting Mimicking Diet (3x5 days in six months) on sperm quality in men

Read the 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.

Being tested
Fasting Mimicking Diet
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
Medical subject headings
Infertility, Male, Oligospermia, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fasting Mimicking DietBehavioural

    Also called Fasting, Dietary Intervention

    The mobile application "Salufast" provides standardised fasting packages for 5 days of approx. 500 kcal and accompanies the participants during all fasting days.

Study groups in NCT04908774
Study groupRoleWhat they receive
Fasting Mimicking Diet GroupExperimentalThe intervention group follows a fasting mimicking diet for 5 days every 6-8 weeks (a total of 3 times in 5 months).
Receives: Behavioral: Fasting Mimicking Diet
Control GroupNo interventionThis group maintains their individual diet during the whole time of the study. After 6 months they are offered a fasting intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Total sperm motility

    WHO-5 spermiogram parameter to measure sperm quality

    Measured: change from baseline to 6 months after baseline

  2. Qualitative interview analysis

    individual and focus group interviews

    Measured: up to 48 weeks after fasting intervention

Secondary outcomes (12)

  1. spermiogram following the WHO-5 criteria

    WHO-5 measurement of sperm quality

    Measured: baseline and approx. every 2 months over the course of a year (12 months)

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. physical fitness

    questionnaire to examine physical fitness

    Measured: 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

  8. Changes in diet

    questionnaire to examine diet

    Measured: 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

  9. quality of relationship

    questionnaire to examine the relationship between the two partners desiring to have a child

    Measured: 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

  10. psychological stress caused by the unfulfilled desire to have children

    questionnaire to examine the psychological stress caused by the unfulfilled desire to have children

    Measured: 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

  11. gratitude

    validated questionnaire to examine gratitude

    Measured: 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

  12. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start25 May 2021
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04908774
Sponsor's protocol ID
KiWu-B
Acronym
KiWu-B
Status last verified
Dec 2023
First submitted
10 May 2021
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available upon request.

Questions about this trial

What is this clinical trial studying?

A study testing Fasting Mimicking Diet in people with Sub Fertility, Male and Fertility Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total sperm motility (time frame: change from baseline to 6 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04908774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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