Effects of a Fasting Mimicking Diet on Sperm Quality (KiWu-B)

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

Study Overview

• Status: Completed
• Conditions: Fertility Disorders; Sub Fertility, Male; Sperm Count, Low
• Intervention / Treatment: Behavioral: Fasting Mimicking Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14109
    • Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting Mimicking Diet Group; 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; 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
No Intervention: Control Group; This group maintains their individual diet during the whole time of the study. After 6 months they are offered a fasting intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total sperm motility	WHO-5 spermiogram parameter to measure sperm quality	change from baseline to 6 months after baseline
Qualitative interview analysis	individual and focus group interviews	up to 48 weeks after fasting intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spermiogram following the WHO-5 criteria	WHO-5 measurement of sperm quality	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.	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.	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.	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.	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.	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	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	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	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	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver sonography	sonography in a subgroup	up to 14 days before, during and up to 14 days after a fasting intervention
reported pregnancy of female partner	questionnaire	up to 12 months after baseline

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Karl and Veronica Carstens Foundation
• Investigators: Principal Investigator: Andreas Michalsen, Prof. Dr., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: fasting; dietary intervention; caloric restriction; natural therapies; lifestyle modification; dietary restriction; sperm motility; fasting mimicking diet; spermiogram; liquefaction time; sperm morphology; total sperm count; sperm density
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male; Oligospermia
• Other Study ID Numbers: KiWu-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request.
• IPD Sharing Time Frame: after the end of the study for 5 years
• IPD Sharing Access Criteria: on demand
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No