Effects of a Fasting Mimicking Diet on Sperm Quality

Fertility Disorders Clinical Trial

— KiWu-B  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908774
• Other study ID #: KiWu-B
• Status: Completed
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Infertility
• Infertility, Male
• Oligospermia
• Sperm Count, Low
• Sub Fertility, Male

Intervention

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.

Locations

Country	Name	City	State
Germany	Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	liver sonography	sonography in a subgroup	up to 14 days before, during and up to 14 days after a fasting intervention
Other	reported pregnancy of female partner	questionnaire	up to 12 months after baseline
Primary	Change in Total sperm motility	WHO-5 spermiogram parameter to measure sperm quality	change from baseline to 6 months after baseline
Primary	Qualitative interview analysis	individual and focus group interviews	up to 48 weeks after fasting intervention
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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