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Effects of a Fasting Mimicking Diet on Sperm Quality

NCT ID: NCT04908774

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2023-10-01

Brief Summary

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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

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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.

Conditions

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Sub Fertility, Male Fertility Disorders Sperm Count, Low

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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).

Group Type EXPERIMENTAL

Fasting Mimicking Diet

Intervention Type BEHAVIORAL

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Fasting Dietary Intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Karl and Veronica Carstens Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Michalsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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KiWu-B

Identifier Type: -

Identifier Source: org_study_id