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| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting Mimicking Diet Group | Experimental | The intervention group follows a fasting mimicking diet for 5 days every 6-8 weeks (a total of 3 times in 5 months). |
|
| Control Group | No Intervention | This group maintains their individual diet during the whole time of the study. After 6 months they are offered a fasting intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting Mimicking Diet | Behavioral | The mobile application "Salufast" provides standardised fasting packages for 5 days of approx. 500 kcal and accompanies the participants during all fasting days. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| liver sonography | sonography in a subgroup | up to 14 days before, during and up to 14 days after a fasting intervention |
| reported pregnancy of female partner | questionnaire |
Inclusion Criteria:
Exclusion Criteria:
biological male sex
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof. Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin | Berlin | 14109 | Germany |
Data will be made available upon request.
after the end of the study for 5 years
on demand
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D009845 | Oligospermia |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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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.
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It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
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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 |
| up to 12 months after baseline |
| D052801 |
| Male Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |