NCT02253056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

September 19, 2014

Last Update Submit

March 30, 2015

Conditions

Healthy Volunteers

Keywords

FastingCaloric RestrictionFocus is to observe effects of fasting in healthy volunteers.

Outcome Measures

Primary Outcomes (1)

  • Insulin-like growth factor 1 and brain-derived neurotrophic factor

    Measurement of changes after 8 weeks

    Baseline and after 8 weeks

Secondary Outcomes (9)

  • Quality of life questionnaire: WHO-5

    Baseline, 8 weeks, 6 month

  • Profile of mood states questionnaire: POMS

    Baseline, 8 weeks, 6 month

  • Anxiety and depression questionnaire: HADS

    Baseline, 8 weeks, 6 month

  • Flourishing questionnaire

    Baseline, 8 weeks, 6 month

  • Visual analogue scales and Likert-scales

    Baseline, 8 weeks, 6 month

  • +4 more secondary outcomes

Study Arms (2)

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

Fasting / Caloric RestrictionOTHER
Fasting
Healthy DietOTHER
Healthy diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 -65 yrs
  • written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immanuel Hospital Berlin

Berlin, State of Berlin, 14109, Germany

Location

Related Links

MeSH Terms

Conditions

Fasting

Interventions

Caloric RestrictionDiet, Healthy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Andreas Michalsen, MD

    Charité Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Andreas Michalsen

Study Record Dates

First Submitted

September 19, 2014

First Posted

October 1, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

DE(1)