Fertility Disorders, Sperm Count, Low, Sub Fertility, Male
Conditions
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
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.
Interventions
BEHAVIORALFasting 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.
Sponsors
Karl and Veronica Carstens Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total sperm motility | change from baseline to 6 months after baseline | WHO-5 spermiogram parameter to measure sperm quality |
| Qualitative interview analysis | up to 48 weeks after fasting intervention | individual and focus group interviews |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Changes in 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 | questionnaire to examine diet |
| quality of relationship | 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 | questionnaire to examine the relationship between the two partners desiring to have a child |
| 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 | questionnaire to examine the psychological stress caused by the unfulfilled desire to have children |
| 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 | validated questionnaire to examine gratitude |
| self-efficacy | 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 | 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 |
| 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 | questionnaire to examine physical fitness |
| spermiogram following the WHO-5 criteria | baseline and approx. every 2 months over the course of a year (12 months) | WHO-5 measurement of sperm quality |
Other
| Measure | Time frame | Description |
|---|---|---|
| liver sonography | up to 14 days before, during and up to 14 days after a fasting intervention | sonography in a subgroup |
| reported pregnancy of female partner | up to 12 months after baseline | questionnaire |
Countries
Germany
Outcome results
None listed