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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT04908774

Collaborator

Karl and Veronica Carstens Foundation (Other)

Enrollment

Location

Arms

18.2

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sub Fertility, Male Fertility Disorders Sperm Count, Low	Behavioral: Fasting Mimicking Diet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.

Primary Purpose:

Treatment

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.

Actual Study Start Date :

May 25, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

spermiogram following the WHO-5 criteria [baseline and approx. every 2 months over the course of a year (12 months)]
WHO-5 measurement of sperm quality
quality of life according to the WHO-5 questionnaire [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 examine quality of life
mindfulness [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
anxiety and 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]
HADS-questionnaire, validated questionnaire to examine anxiety and depression
current 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]
ASTS-questionnaire, validated questionnaire to examine current mood
experienced stress [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
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]
questionnaire to examine physical fitness
Changes in 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]
questionnaire to examine diet
quality of relationship [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
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]
questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
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]
validated questionnaire to examine gratitude
self-efficacy [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

Other Outcome Measures

liver sonography [up to 14 days before, during and up to 14 days after a fasting intervention]
sonography in a subgroup
reported pregnancy of female partner [up to 12 months after baseline]
questionnaire