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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Healthy Diet; Other: Fasting / Caloric Restriction

• Registration Number: NCT02253056
• Lead Sponsor: Charite University, Berlin, Germany

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-10-01
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• age 18 -65 yrs
• written informed consent

Exclusion Criteria

• severe chronic comorbidity
• eating disorders
• pregnancy
• planed pregnancy
• simultaneous participation in other trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy diet	Healthy Diet	Regular healthy diet according to current German (DGE) guidelines for healthy nutrition.
Fasting	Fasting / Caloric Restriction	Intermittent fasting over 8 weeks (one day per week)

Primary Outcome Measures

Name	Time	Method
Insulin-like growth factor 1 and brain-derived neurotrophic factor	Baseline and after 8 weeks	Measurement of changes after 8 weeks

Secondary Outcome Measures

Name	Time	Method
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
Systolic and diastolic bloodpressure	Baseline, 8 weeks	Measurement of changes after 8 weeks
Body Impedance Analysis (BIA)	Baseline, 8 weeks	Measurement of changes after 8 weeks
Body weight and abdominal circumference	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

Trial Locations

Locations (1)

Immanuel Hospital Berlin; 🇩🇪 Berlin, Germany