Health BehaviorBFNCT03443739
Effects of Fasting in the Bahá'í Faith
An observational study of Health Behavior and Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Healthy
- What is being tested?
- Intermittent Fasting
- How many people
- 145 participants
- Where
- 1 siteGermany
- Study dates
- 19 Feb 2018to 31 Jul 2019
- Phase
- Observational
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Members of the Bahá'í community residing in Germany
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Behavior, Healthy
- Being tested
- Intermittent Fasting
- Keywords
- Intermittent Fasting, Religious Fast, Bahá'í, Hydration, Calorimetry, Microdialysis, circadian clock, circadian rhythm, spirituality, self-efficacy
- Medical subject headings
- Health Behavior, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
Intermittent Fasting with abstinence from food and drink daily from sunrise to sunset for nineteen consecutive days in March 2018
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Osmolarity
Measured in subsample of study participants (venous blood sample) osmol/l
Measured: 12 hours
In 2019: Validation of new questionnaire
New questionnaire, developed in 2018, regarding Bahai fasting
Measured: 1 hour
Secondary outcomes (2)
Urine Osmolality
Measured in subsample of participants, in spontaneous Urine sample and 12h/24h Urine samples osmol/kg
Measured: 24 hours
Acid-base balance
Measured in subsample of study participants (venous blood sample) Measured with Radiometer, Base excess (mmol/l)
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start19 Feb 2018
- Primary completion30 Apr 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Münster
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443739
- Sponsor's protocol ID
- Bahá'í fast
- Acronym
- BF
- Status last verified
- Dec 2022
- First submitted
- 17 Feb 2018
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34395487Mahler 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.
PubMed 35011024Steckhan N, Ring R, Borchert F, Koppold DA. Triangulation of Questionnaires, Qualitative Data and Natural Language Processing: A Differential Approach to Religious Baha'i Fasting in Germany. J Relig Health. 2024 Oct;63(5):3360-3373. doi: 10.1007/s10943-023-01929-x. Epub 2023 Oct 25.
PubMed 37878201
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical And Psychological Effects of Nineteen Days of Intermittent Religious Fasting for Followers of the Bahá'í Faith- an Observational Study
- ClinicalTrials.gov ID
- NCT03443739
- Acronym / sponsor ID
- BF / Bahá'í fast
- Conditions
- Health Behavior, Healthy
- Keywords
- Intermittent Fasting, Religious Fast, Bahá'í, Hydration, Calorimetry, Microdialysis, circadian clock, circadian rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Universität Münster
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the Bahá'í community residing in Germany
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Intermittent FastingIntermittent Fasting with abstinence from food and drink daily from sunrise to sunset for nineteen consecutive days in March 2018 | Other | – |
Primary outcome
Serum Osmolarity
Time frame: 12 hours
Measured in subsample of study participants (venous blood sample) osmol/l
In 2019: Validation of new questionnaire
Time frame: 1 hour
New questionnaire, developed in 2018, regarding Bahai fasting
2 secondary outcomes
Urine Osmolality
Time frame: 24 hours
Acid-base balance
Time frame: 5 Minutes
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 14 Dec 2022.
- Results publication: PubMed 34395487Koppold-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.
- Results publication: PubMed 35011024Mahler 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.
- Derived from this study: PubMed 37878201Steckhan N, Ring R, Borchert F, Koppold DA. Triangulation of Questionnaires, Qualitative Data and Natural Language Processing: A Differential Approach to Religious Baha'i Fasting in Germany. J Relig Health. 2024 Oct;63(5):3360-3373. doi: 10.1007/s10943-023-01929-x. Epub 2023 Oct 25.
- Results publication 1Link 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, Prof. Dr. principal investigator
Charité University Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Healthy, 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 1 inclusion and 4 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 14 Dec 2022. 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?
Serum Osmolarity (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443739, which also lists 3 linked publications.
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 14 Dec 2022.