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Completed

NCT Number: NCT04908774

Effects of a Fasting Mimicking Diet on Sperm Quality

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

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Key information

Conditions

Sub Fertility, Male Behavior Fasting Feeding Behavior Fertility Disorders Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Oligospermia Sperm Count, Low Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Berlin, 14109, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fasting mimicking diet

Behavioral

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

Other names: Fasting, Dietary Intervention

Primary outcomes

  1. Change in Total sperm motility

    Time frame: change from baseline to 6 months after baseline

    WHO-5 spermiogram parameter to measure sperm quality

  2. Qualitative interview analysis

    Time frame: up to 48 weeks after fasting intervention

    individual and focus group interviews

Secondary outcomes

  1. spermiogram following the WHO-5 criteria

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

    WHO-5 measurement of sperm quality

  2. quality of life according to the WHO-Five Well-Being Index

    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

    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.

  3. mindfulness

    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

    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.

  4. anxiety and 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

    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.

  5. current 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

    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.

  6. experienced stress

    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

    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.

  7. 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

    questionnaire to examine physical fitness

  8. Changes in 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

    questionnaire to examine diet

  9. quality of relationship

    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

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

  10. 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

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

  11. 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

    validated questionnaire to examine gratitude

  12. self-efficacy

    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

    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

Other outcomes

  1. liver sonography

    Time frame: up to 14 days before, during and up to 14 days after a fasting intervention

    sonography in a subgroup

  2. reported pregnancy of female partner

    Time frame: up to 12 months after baseline

    questionnaire

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Karl and Veronica Carstens Foundation

Registry information

Official study 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.

Acronym: KiWu-B

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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