Montag Ist Fasten-Tag (German) - MIFT [Monday is Fasting Day]
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Insulin-like growth factor 1 and brain-derived neurotrophic factor
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Insulin-like growth factor 1 and brain-derived neurotrophic factor
Time Frame: Baseline and after 8 weeks
Measurement of changes after 8 weeks
Secondary Outcomes
- Visual analogue scales and Likert-scales(Baseline, 8 weeks, 6 month)
- Profile of mood states questionnaire: POMS(Baseline, 8 weeks, 6 month)
- Anxiety and depression questionnaire: HADS(Baseline, 8 weeks, 6 month)
- Flourishing questionnaire(Baseline, 8 weeks, 6 month)
- Quality of life questionnaire: WHO-5(Baseline, 8 weeks, 6 month)
- Systolic and diastolic bloodpressure(Baseline, 8 weeks)
- Body Impedance Analysis (BIA)(Baseline, 8 weeks)
- Body weight and abdominal circumference(Baseline, 8 weeks)
- Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR(Baseline and 8 weeks)
Investigators
Andreas Michalsen
Prof. Dr. med. Andreas Michalsen
Charite University, Berlin, Germany