Effects of a Fasting Mimicking Diet on Sperm Quality

Study Overview
=================
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.

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.

Conditions
-----------------
Sub Fertility, Male, Fertility Disorders, Sperm Count, Low

Intervention / Treatment
-----------------
* Behavioral: Fasting Mimicking Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting Mimicking Diet Group<br>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<br>* The mobile application Salufast provides standardised fasting packages for 5 days of approx. 500 kcal and accompanies the participants during all fasting days.<br>* Other names: Dietary Intervention;|
| No Intervention: Control Group<br>This group maintains their individual diet during the whole time of the study. After 6 months they are offered a fasting intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spermiogram following the WHO-5 criteria | WHO-5 measurement of sperm quality | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 
| 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. | 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 | 
| physical fitness | questionnaire to examine 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 | 
| Changes in diet | questionnaire to examine 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 | 
| quality of relationship | questionnaire to examine the relationship between the two partners desiring to have a child | 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 | 
| psychological stress caused by the unfulfilled desire to have children | questionnaire to examine the 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 | 
| gratitude | validated questionnaire to examine 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 | 
| 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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