ClinicalTrials.gg
CompletedNCT03443739BFUpdated Dec 14, 2022

Effects of Fasting in the Bahá'í Faith

An observational study in Health Behavior and Healthy, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
145
Ages
18 Years to 69 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Health Behavior
  • Healthy

Keywords

  • Intermittent Fasting
  • Religious Fast
  • Bahá'í
  • Hydration
  • Calorimetry
  • Microdialysis
  • circadian clock
  • circadian rhythm
  • spirituality
  • self-efficacy
03

In context

Health Behavior

967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.

This study's enrollment of 145 is below the median of 219 across 131 observational studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Members of the Bahá'í community residing in Germany

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)

  • \<18,0 und >30,9 kg/m2, claustrophobia, 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
145 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherIntermittent Fasting

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

06

What researchers measure

Primary outcomes

  1. Serum Osmolarity

    Measured in subsample of study participants (venous blood sample) osmol/l

    Time frame: 12 hours

  2. In 2019: Validation of new questionnaire

    New questionnaire, developed in 2018, regarding Bahai fasting

    Time frame: 1 hour

Secondary outcomes

  1. Urine Osmolality

    Measured in subsample of participants, in spontaneous Urine sample and 12h/24h Urine samples osmol/kg

    Time frame: 24 hours

  2. Acid-base balance

    Measured in subsample of study participants (venous blood sample) Measured with Radiometer, Base excess (mmol/l)

    Time frame: 5 Minutes

Other outcomes

  1. Questionnaire: HADS (Hospital Anxiety and Depression Score)

    Anxiety and depression

    Time frame: 5 Minutes

  2. Systolic and diastolic blood pressure

    Measured in subsample of study participants Measured by clinician, mmHg

    Time frame: 5 Minutes

  3. BMI

    Measured in subsample of study participants Quantitative, kg/m2

    Time frame: 10 Minutes

  4. Microdialysis

    Measured in subsample of study participants

    Time frame: 3 hours

  5. Indirect calorimetry

    Measured in subsample of study participants

    Time frame: 2 hours

  6. Individual Interview

    Measured in subsample of study participants

    Time frame: 30 Minutes, three times during study

  7. Activation of clock genes

    Measured in subsample of study participants Measured in monocytes

    Time frame: 3 Minutes

07

Study locations

1 site
  • Charité
    Berlin, 14109, Germany
08

References and documents

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 34395487 ↗
  • 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. PubMed 35011024 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03443739
Collaborators
Universität Münster
Responsible party
Andreas Michalsen (Clinical professor, Charite University, Berlin, Germany) — Principal investigator
First posted
Feb 23, 2018
Start date
Feb 19, 2018
Primary completion
Apr 30, 2018
Completion
Jul 31, 2019
Last update
Dec 14, 2022

Study contacts

Andreas Michalsen, Prof. Dr.
principal investigator · Charité University Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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