Healthy Volunteers
Conditions
Keywords
Fasting, Caloric Restriction, Focus is to observe effects of fasting in healthy volunteers.
Brief summary
The aim of this pilot study is to evaluate the effects of one regular fasting day per week over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.
Detailed description
Participants in the intervention group receive an initial group training for fasting. Then all participants will observe one fixed fasting day per week (monday) over a total period of eight weeks. Participants in the control group receive an initial group training for healthy diet according to current German guidelines (DGE). Moreover, they will receive the same offer as in the intervention group at the end of the 8-week study period. Until then the control group participants follow a regular healthy diet.
Interventions
OTHERFasting / Caloric Restriction
OTHERHealthy Diet
Sponsors
Immanuel Hospital, Berlin, Germany
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18 -65 yrs * written informed consent
Exclusion criteria
* severe chronic comorbidity * eating disorders * pregnancy * planed pregnancy * simultaneous participation in other trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin-like growth factor 1 and brain-derived neurotrophic factor | Baseline and after 8 weeks | Measurement of changes after 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of mood states questionnaire: POMS | Baseline, 8 weeks, 6 month | Questionnaire |
| Anxiety and depression questionnaire: HADS | Baseline, 8 weeks, 6 month | Questionnaire |
| Flourishing questionnaire | Baseline, 8 weeks, 6 month | Questionnaire |
| Visual analogue scales and Likert-scales | Baseline, 8 weeks, 6 month | Questionnaire |
| Quality of life questionnaire: WHO-5 | Baseline, 8 weeks, 6 month | Questionnaire |
| Body weight and abdominal circumference | Baseline, 8 weeks | Measurement of changes after 8 weeks |
| Systolic and diastolic bloodpressure | Baseline, 8 weeks | Measurement of changes after 8 weeks |
| Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR | Baseline and 8 weeks | Changes after 8 weeks |
| Body Impedance Analysis (BIA) | Baseline, 8 weeks | Measurement of changes after 8 weeks |
Countries
Germany
Outcome results
None listed