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

Healthy Volunteers Clinical Trial

— MIFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253056
• Other study ID #: MIFT-Trial
• Status: Completed
• Phase: N/A
• First received: September 19, 2014
• Last updated: March 30, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Fasting / Caloric Restriction

• Healthy Diet

Locations

Country	Name	City	State
Germany	Immanuel Hospital Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Immanuel Hospital, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin-like growth factor 1 and brain-derived neurotrophic factor	Measurement of changes after 8 weeks	Baseline and after 8 weeks	No
Secondary	Quality of life questionnaire: WHO-5	Questionnaire	Baseline, 8 weeks, 6 month	No
Secondary	Profile of mood states questionnaire: POMS	Questionnaire	Baseline, 8 weeks, 6 month	No
Secondary	Anxiety and depression questionnaire: HADS	Questionnaire	Baseline, 8 weeks, 6 month	No
Secondary	Flourishing questionnaire	Questionnaire	Baseline, 8 weeks, 6 month	No
Secondary	Visual analogue scales and Likert-scales	Questionnaire	Baseline, 8 weeks, 6 month	No
Secondary	Body Impedance Analysis (BIA)	Measurement of changes after 8 weeks	Baseline, 8 weeks	No
Secondary	Body weight and abdominal circumference	Measurement of changes after 8 weeks	Baseline, 8 weeks	No
Secondary	Systolic and diastolic bloodpressure	Measurement of changes after 8 weeks	Baseline, 8 weeks	No
Secondary	Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR	Changes after 8 weeks	Baseline and 8 weeks	No

External Links

•   Research Institute´s Homepage