Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Montag Ist Fasten-Tag (German) - MIFT [Monday is Fasting Day]

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Fasting / Caloric Restriction
* Other: Healthy Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 -65 yrs written informed consent Exclusion Criteria: severe chronic comorbidity eating disorders pregnancy planed pregnancy simultaneous participation in other trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting<br>Intermittent fasting over 8 weeks (one day per week) | Other: Fasting / Caloric Restriction<br> <br> |
| Active Comparator: Healthy diet<br>Regular healthy diet according to current German (DGE) guidelines for healthy nutrition. | Other: Healthy Diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin-like growth factor 1 and brain-derived neurotrophic factor | Measurement of changes after 8 weeks | Baseline and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire: WHO-5 | Questionnaire | Baseline, 8 weeks, 6 month | 
| Profile of mood states questionnaire: POMS | Questionnaire | Baseline, 8 weeks, 6 month | 
| Anxiety and depression questionnaire: HADS | Questionnaire | Baseline, 8 weeks, 6 month | 
| Flourishing questionnaire | Questionnaire | Baseline, 8 weeks, 6 month | 
| Visual analogue scales and Likert-scales | Questionnaire | Baseline, 8 weeks, 6 month | 
| Body Impedance Analysis (BIA) | Measurement of changes after 8 weeks | Baseline, 8 weeks | 
| Body weight and abdominal circumference | Measurement of changes after 8 weeks | Baseline, 8 weeks | 
| Systolic and diastolic bloodpressure | Measurement of changes after 8 weeks | Baseline, 8 weeks | 
| Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR | Changes after 8 weeks | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fasting, Caloric Restriction, Focus is to observe effects of fasting in healthy volunteers.