Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting (MIFT)

March 30, 2015 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Immanuel Hospital Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin-like growth factor 1 and brain-derived neurotrophic factor
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline, 8 weeks, 6 month
Questionnaire
Baseline, 8 weeks, 6 month
Profile of mood states questionnaire: POMS
Time Frame: Baseline, 8 weeks, 6 month
Questionnaire
Baseline, 8 weeks, 6 month
Anxiety and depression questionnaire: HADS
Time Frame: Baseline, 8 weeks, 6 month
Questionnaire
Baseline, 8 weeks, 6 month
Flourishing questionnaire
Time Frame: Baseline, 8 weeks, 6 month
Questionnaire
Baseline, 8 weeks, 6 month
Visual analogue scales and Likert-scales
Time Frame: Baseline, 8 weeks, 6 month
Questionnaire
Baseline, 8 weeks, 6 month
Body Impedance Analysis (BIA)
Time Frame: Baseline, 8 weeks
Measurement of changes after 8 weeks
Baseline, 8 weeks
Body weight and abdominal circumference
Time Frame: Baseline, 8 weeks
Measurement of changes after 8 weeks
Baseline, 8 weeks
Systolic and diastolic bloodpressure
Time Frame: Baseline, 8 weeks
Measurement of changes after 8 weeks
Baseline, 8 weeks
Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR
Time Frame: Baseline and 8 weeks
Changes after 8 weeks
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Immanuel Hospital, Berlin, Germany

Investigators

  • Principal Investigator: Andreas Michalsen, MD, Charité Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 26, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MIFT-Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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