Effects of Fasting in the Bahá'í Faith

Healthy Clinical Trial

— BF  

Official title:

Medical And Psychological Effects of Nineteen Days of Intermittent Religious Fasting for Followers of the Bahá'í Faith- an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443739
• Other study ID #: Bahá'í fast
• Status: Completed
• Start date: February 19, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 31, 2019
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Healthy

Intervention

Other:
• Intermittent Fasting
Intermittent Fasting with abstinence from food and drink daily from sunrise to sunset for nineteen consecutive days in March 2018

Locations

Country	Name	City	State
Germany	Charité	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Westfälische Wilhelms-Universität Münster

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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 Me — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire: HADS (Hospital Anxiety and Depression Score)	Anxiety and depression	5 Minutes
Other	Systolic and diastolic blood pressure	Measured in subsample of study participants Measured by clinician, mmHg	5 Minutes
Other	BMI	Measured in subsample of study participants Quantitative, kg/m2	10 Minutes
Other	Microdialysis	Measured in subsample of study participants	3 hours
Other	Indirect calorimetry	Measured in subsample of study participants	2 hours
Other	Individual Interview	Measured in subsample of study participants	30 Minutes, three times during study
Other	Activation of clock genes	Measured in subsample of study participants Measured in monocytes	3 Minutes
Primary	Serum Osmolarity	Measured in subsample of study participants (venous blood sample) osmol/l	12 hours
Primary	In 2019: Validation of new questionnaire	New questionnaire, developed in 2018, regarding Bahai fasting	1 hour
Secondary	Urine Osmolality	Measured in subsample of participants, in spontaneous Urine sample and 12h/24h Urine samples osmol/kg	24 hours
Secondary	Acid-base balance	Measured in subsample of study participants (venous blood sample) Measured with Radiometer, Base excess (mmol/l)	5 Minutes

External Links

•   Results publication 1
•   Results publication 2