Monday is Fasting Day - Non-Randomized Trial on Intermitt... | NCT02253056

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

NCT02253056

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Mar 31, 2015Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Fasting / Caloric Restriction
Healthy Diet

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Sep 19, 2014

First Submission Date that Met QC Criteria

Sep 26, 2014

First Posted Date

Oct 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Michalsen, Prof. Dr. med. Andreas Michalsen, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
Immanuel Hospital, Berlin, Germany	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fasting / Caloric Restriction	Other		Fasting
Healthy Diet

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Quality of life questionnaire: WHO-5	Questionnaire	Baseline, 8 weeks, 6 month
Profile of mood states questionnaire: POMS	Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 -65 yrs
written informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Michalsen, MD	Charité Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Immanuel Hospital Berlin		Berlin	State of Berlin	14109	Germany

Label	URL
Research Institute´s Homepage	View source

ID	Term
D005215	Fasting

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D031204	Caloric Restriction
D000072001	Diet, Healthy

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D002149	Energy Intake

Browse Leaves

Not provided

Browse Branches

Not provided