Healthy volunteers (no severe illnessess)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - = 18 years of age - Voluntary participation - Written informed consent - Ability to understand nature and effects of the trial participation
Exclusion criteria
Exclusion criteria: - Body mass index 10% of body weight in the last 6 months - Current or recent diet aimed at reducing weight - Current or past eating disorders - Acute medical conditions (including ulcus/gastritis) - Chronic or acute heart, liver or kidney disease - Diabetes mellitus type I - Large surgical procedures in the last 6 months - Pregnancy & breastfeeding period - Participation in another interventional trial likely to interfere with the study outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short- and long-term changes in quality of life (WHO-5, SF-36 quetsionnaires) and fatigue (FACIT, FAS questionnaires) | — |
Secondary
| Measure | Time frame |
|---|---|
| Short- and long-term laboratory changes reflecting the general health status (including fat metabolism, kidney and liver function, blood sugars etc.) | — |
Countries
Germany
Contacts
Universitätsklinikum Mainz der Johannes Gutenberg Universität MainzAbteilung für Frauengesundheit und Geburtshilfe