Clinical trial NCT03443739: Effects of Fasting in the Bahá'í Faith
Official title: Medical And Psychological Effects of Nineteen Days of Intermittent Religious Fasting for Followers of the Bahá'í Faith- an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Healthy
Keywords: Intermittent Fasting
Religious Fast
Bahá'í
Hydration
Calorimetry
Microdialysis
circadian clock
circadian rhythm
spirituality
self-efficacy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Universität Münster
First posted: 2018-02-23
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the Bahá'í community residing in Germany

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Osmolarity
timeFrame: 12 hours
measure: In 2019: Validation of new questionnaire
timeFrame: 1 hour
Secondary outcomes:
measure: Urine Osmolality
timeFrame: 24 hours
measure: Acid-base balance
timeFrame: 5 Minutes
Other outcomes:
measure: Questionnaire: HADS (Hospital Anxiety and Depression Score)
timeFrame: 5 Minutes
measure: Systolic and diastolic blood pressure
timeFrame: 5 Minutes
measure: BMI
timeFrame: 10 Minutes
measure: Microdialysis
timeFrame: 3 hours
measure: Indirect calorimetry
timeFrame: 2 hours
measure: Individual Interview
timeFrame: 30 Minutes, three times during study
measure: Activation of clock genes
timeFrame: 3 Minutes
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charité University Medicine
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.