Effects of a Fasting Mimicking Diet on Sperm Quality - Clinical Trial for Sub Fertility, Male | NCT04908774

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Fasting Mimicking Diet

About this trial

This is an interventional treatment trial for Sub Fertility, Male focused on measuring 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

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fasting Mimicking Diet Group

Control Group

Arm Description

The intervention group follows a fasting mimicking diet for 5 days every 6-8 weeks (a total of 3 times in 5 months).

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

Outcomes

Primary Outcome Measures

Change in Total sperm motility

WHO-5 spermiogram parameter to measure sperm quality

Qualitative interview analysis

individual and focus group interviews

Secondary Outcome Measures

spermiogram following the WHO-5 criteria

WHO-5 measurement of sperm quality

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.

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.

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.

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.

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.

physical fitness

questionnaire to examine physical fitness

Changes in diet

questionnaire to examine diet

quality of relationship

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

psychological stress caused by the unfulfilled desire to have children

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

gratitude

validated questionnaire to examine gratitude

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

Full Information

NCT ID

NCT04908774

First Posted

May 10, 2021

Last Updated

December 12, 2022

Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04908774

Brief Title

Effects of a Fasting Mimicking Diet on Sperm Quality

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 25, 2021 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

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.

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fasting Mimicking Diet Group

Arm Type

Experimental

Arm Description

The intervention group follows a fasting mimicking diet for 5 days every 6-8 weeks (a total of 3 times in 5 months).

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Fasting Mimicking Diet

Other Intervention Name(s)

Fasting, Dietary Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Total sperm motility

Description

WHO-5 spermiogram parameter to measure sperm quality

Time Frame

change from baseline to 6 months after baseline

Title

Qualitative interview analysis

Description

individual and focus group interviews

Time Frame

up to 48 weeks after fasting intervention

Secondary Outcome Measure Information:

Title

spermiogram following the WHO-5 criteria

Description

WHO-5 measurement of sperm quality

Time Frame

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

Title

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

Description

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.

Time Frame