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

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.

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.

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

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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