Effects of a Fasting Mimicking Diet on Sperm Quality

NCT04908774 | Completed DMC

• 1 other identifier: KiWu-B
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Sub Fertility, Male; Fertility Disorders; Sperm Count, Low

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• spermiogram following the WHO-5 criteria

  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

  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

  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

  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

  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 Outcomes (2)

• liver sonography

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

• reported pregnancy of female partner

  up to 12 months after baseline

Study Arms (2)

Fasting Mimicking Diet Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

This group maintains their individual diet during the whole time of the study. After 6 months they are offered a fasting intervention.

Interventions

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.

Also known as: Fasting, Dietary Intervention

Fasting Mimicking Diet Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: biological male sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• kg/m² \<= BMI \<= 35 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (1)

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Berlin, 14109, Germany

Location

MeSH Terms

Conditions

Infertility, Male; Oligospermia; Fasting

Interventions

Angptl4 protein, mouse; Diet Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Andreas Michalsen, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 1, 2021
• Study Start: May 25, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: after the end of the study for 5 years
• Access Criteria: on demand

Locations

DE (1)