- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443739
Effects of Fasting in the Bahá'í Faith (BF)
December 12, 2022 updated by: Andreas Michalsen, Charite University, Berlin, Germany
Medical And Psychological Effects of Nineteen Days of Intermittent Religious Fasting for Followers of the Bahá'í Faith- an Observational Study
The aim of the study is to find out the effects a specific religious fast (i.e.
Bahá'í fast) has on certain metabolic parameters, hydration, psyche and circadian clock.
In a follow-up questionnaire series in 2019 we want to additionally validate a specific questionnaire for Bahai fasting, which was developed in 2018.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Followers of the Bahá'í Faith worldwide follow a yearly fasting tradition, where they fast intermittently for nineteen days.
The intermittent fast is defined as abstinence from any food, drink and smoking from sunrise until sunset.
These nineteen days are always in March and so do not coincide with climatic extremes in any country worldwide.
This makes this kind of fasting a good model to study the psychological and medical effects of intermittent fasting in humans.
Study Type
Observational
Enrollment (Actual)
145
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
-
-
-
Berlin, Germany, 14109
- Charité
-
-
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 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Members of the Bahá'í community residing in Germany
Description
Inclusion Criteria:
- member of the Bahá'í religious community, Age between 18-69 years, the study participant must be able to understand the instructions given to him by the study personnel, the performance of the religious fast is planned in 2018 (and for the validation of the questionnaire also in 2019)
Exclusion Criteria:
- An interruption of the religious fast is planned for more than five days, pregnant and nursing women, severe internistic condition, eating disorders (anorexia nervosa, bulimia), terminal or severe disease with marked impairments in mobility and vitality, non-existence of email address and Internet Access (because of online questionnaires), severe psychiatric disorder, simultaneous participation in another Trial
Exclusion Criteria for subsample (energy metabolism measurements and microdialysis)
- Body Mass Index <18,0 und >30,9 kg/m2, claustrophobia, clinically relevant haemostaseological conditions or medication, vegan diet, special diet out of medical reasons, current dieting for weight loss, weight loss of more than 2 kg in the month before the study commenced, postsurgical conditions, acute and chronic infections, known drug or alcohol abuse
- additional exclusion criteria for microdialysis (subsample of energy metabolism measurements): allergy to local anaesthetics
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Osmolarity
Time Frame: 12 hours
|
Measured in subsample of study participants (venous blood sample) osmol/l
|
12 hours
|
In 2019: Validation of new questionnaire
Time Frame: 1 hour
|
New questionnaire, developed in 2018, regarding Bahai fasting
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine Osmolality
Time Frame: 24 hours
|
Measured in subsample of participants, in spontaneous Urine sample and 12h/24h Urine samples osmol/kg
|
24 hours
|
Acid-base balance
Time Frame: 5 Minutes
|
Measured in subsample of study participants (venous blood sample) Measured with Radiometer, Base excess (mmol/l)
|
5 Minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire: HADS (Hospital Anxiety and Depression Score)
Time Frame: 5 Minutes
|
Anxiety and depression
|
5 Minutes
|
Systolic and diastolic blood pressure
Time Frame: 5 Minutes
|
Measured in subsample of study participants Measured by clinician, mmHg
|
5 Minutes
|
BMI
Time Frame: 10 Minutes
|
Measured in subsample of study participants Quantitative, kg/m2
|
10 Minutes
|
Microdialysis
Time Frame: 3 hours
|
Measured in subsample of study participants
|
3 hours
|
Indirect calorimetry
Time Frame: 2 hours
|
Measured in subsample of study participants
|
2 hours
|
Individual Interview
Time Frame: 30 Minutes, three times during study
|
Measured in subsample of study participants
|
30 Minutes, three times during study
|
Activation of clock genes
Time Frame: 3 Minutes
|
Measured in subsample of study participants Measured in monocytes
|
3 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andreas Michalsen, Prof. Dr., Charité University Medicine
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.
General Publications
- Koppold-Liebscher DA, Klatte C, Demmrich S, Schwarz J, Kandil FI, Steckhan N, Ring R, Kessler CS, Jeitler M, Koller B, Ananthasubramaniam B, Eisenmann C, Mahler A, Boschmann M, Kramer A, Michalsen A. Effects of Daytime Dry Fasting on Hydration, Glucose Metabolism and Circadian Phase: A Prospective Exploratory Cohort Study in Baha'i Volunteers. Front Nutr. 2021 Jul 29;8:662310. doi: 10.3389/fnut.2021.662310. eCollection 2021.
- Mahler A, Jahn C, Klug L, Klatte C, Michalsen A, Koppold-Liebscher D, Boschmann M. Metabolic Response to Daytime Dry Fasting in Baha'i Volunteers-Results of a Preliminary Study. Nutrients. 2021 Dec 29;14(1):148. doi: 10.3390/nu14010148.
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 (Actual)
February 19, 2018
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
February 17, 2018
First Submitted That Met QC Criteria
February 19, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
December 14, 2022
Last Update Submitted That Met QC Criteria
December 12, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Bahá'í fast
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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