Healthy VolunteersMIFTNCT02253056
Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting
A study testing Fasting / Caloric Restriction and Healthy Diet in people with Healthy Volunteers, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fasting / Caloric Restriction and Healthy Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 -65 yrs
- written informed consent
Who cannot join
- severe chronic comorbidity
- eating disorders
- pregnancy
- planed pregnancy
- simultaneous participation in other trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Fasting / Caloric Restriction, Healthy Diet
- Keywords
- Fasting, Caloric Restriction, Focus is to observe effects of fasting in healthy volunteers.
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting / Caloric RestrictionOther
Healthy DietOther
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Intermittent fasting over 8 weeks (one day per week) Receives: Other: Fasting / Caloric Restriction |
| Healthy diet | Active comparator | Regular healthy diet according to current German (DGE) guidelines for healthy nutrition. Receives: Other: Healthy Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin-like growth factor 1 and brain-derived neurotrophic factor
Measurement of changes after 8 weeks
Measured: Baseline and after 8 weeks
Secondary outcomes (9)
Quality of life questionnaire: WHO-5
Questionnaire
Measured: Baseline, 8 weeks, 6 month
Profile of mood states questionnaire: POMS
Questionnaire
Measured: Baseline, 8 weeks, 6 month
Anxiety and depression questionnaire: HADS
Questionnaire
Measured: Baseline, 8 weeks, 6 month
Flourishing questionnaire
Questionnaire
Measured: Baseline, 8 weeks, 6 month
Visual analogue scales and Likert-scales
Questionnaire
Measured: Baseline, 8 weeks, 6 month
Body Impedance Analysis (BIA)
Measurement of changes after 8 weeks
Measured: Baseline, 8 weeks
Body weight and abdominal circumference
Measurement of changes after 8 weeks
Measured: Baseline, 8 weeks
Systolic and diastolic bloodpressure
Measurement of changes after 8 weeks
Measured: Baseline, 8 weeks
Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR
Changes after 8 weeks
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Immanuel Hospital, Berlin, Germany
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, MD, Principal investigator, Charité Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253056
- Sponsor's protocol ID
- MIFT-Trial
- Acronym
- MIFT
- Status last verified
- Mar 2015
- First submitted
- 19 Sep 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montag Ist Fasten-Tag (German) - MIFT [Monday is Fasting Day]
- ClinicalTrials.gov ID
- NCT02253056
- Acronym / sponsor ID
- MIFT / MIFT-Trial
- Conditions
- Healthy Volunteers
- Keywords
- Fasting, Caloric Restriction, Focus is to observe effects of fasting in healthy volunteers.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Immanuel Hospital, Berlin, Germany
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Other: Fasting / Caloric RestrictionIntermittent fasting over 8 weeks (one day per week) |
| Healthy diet | Active comparator | Other: Healthy DietRegular healthy diet according to current German (DGE) guidelines for healthy nutrition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 -65 yrs
- written informed consent
Key exclusion criteria (5 listed)
- severe chronic comorbidity
- eating disorders
- pregnancy
- planed pregnancy
- simultaneous participation in other trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting / Caloric Restriction | Other | Fasting |
| Healthy Diet | Other | Healthy diet |
Primary outcome
Insulin-like growth factor 1 and brain-derived neurotrophic factor
Time frame: Baseline and after 8 weeks
Measurement of changes after 8 weeks
9 secondary outcomes
Quality of life questionnaire: WHO-5
Time frame: Baseline, 8 weeks, 6 month
Profile of mood states questionnaire: POMS
Time frame: Baseline, 8 weeks, 6 month
Anxiety and depression questionnaire: HADS
Time frame: Baseline, 8 weeks, 6 month
Flourishing questionnaire
Time frame: Baseline, 8 weeks, 6 month
Visual analogue scales and Likert-scales
Time frame: Baseline, 8 weeks, 6 month
Body Impedance Analysis (BIA)
Time frame: Baseline, 8 weeks
Body weight and abdominal circumference
Time frame: Baseline, 8 weeks
Systolic and diastolic bloodpressure
Time frame: Baseline, 8 weeks
Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Research Institute´s HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, MD principal investigator
Charité Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting / Caloric Restriction and Healthy Diet in people with Healthy Volunteers, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin-like growth factor 1 and brain-derived neurotrophic factor (time frame: Baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.