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

Charité University Medicine Berlin

Status: Completed

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

Treatments: Behavioral: Fasting Mimicking Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04908774

KiWu-B

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Fasting Mimicking Diet Group

Experimental group

Description:

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

Treatment:

Behavioral: Fasting Mimicking Diet

Control Group

No Intervention group

Description:

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