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Effects of Fasting in the Bahá'í Faith (BF)

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ClinicalTrials.gov Identifier: NCT03443739
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Westfälische Wilhelms-Universität Münster
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, 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.

Condition or disease Intervention/treatment
Health Behavior Healthy Other: Intermittent Fasting

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.

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Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical And Psychological Effects of Nineteen Days of Intermittent Religious Fasting for Followers of the Bahá'í Faith- an Observational Study
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : April 30, 2018
Estimated Study Completion Date : July 3, 2019

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


Primary Outcome Measures :
  1. Serum Osmolarity [ Time Frame: 12 hours ]
    Measured in subsample of study participants (venous blood sample) osmol/l

  2. In 2019: Validation of new questionnaire [ Time Frame: 1 hour ]
    New questionnaire, developed in 2018, regarding Bahai fasting


Secondary Outcome Measures :
  1. Urine Osmolality [ Time Frame: 24 hours ]
    Measured in subsample of participants, in spontaneous Urine sample and 12h/24h Urine samples osmol/kg

  2. Acid-base balance [ Time Frame: 5 Minutes ]
    Measured in subsample of study participants (venous blood sample) Measured with Radiometer, Base excess (mmol/l)


Other Outcome Measures:
  1. Questionnaire: HADS (Hospital Anxiety and Depression Score) [ Time Frame: 5 Minutes ]
    Anxiety and depression

  2. Systolic and diastolic blood pressure [ Time Frame: 5 Minutes ]
    Measured in subsample of study participants Measured by clinician, mmHg

  3. BMI [ Time Frame: 10 Minutes ]
    Measured in subsample of study participants Quantitative, kg/m2

  4. Microdialysis [ Time Frame: 3 hours ]
    Measured in subsample of study participants

  5. Indirect calorimetry [ Time Frame: 2 hours ]
    Measured in subsample of study participants

  6. Individual Interview [ Time Frame: 30 Minutes, three times during study ]
    Measured in subsample of study participants

  7. Activation of clock genes [ Time Frame: 3 Minutes ]
    Measured in subsample of study participants Measured in monocytes


Biospecimen Retention:   Samples Without DNA
Blood, urine


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Members of the Bahá'í community residing in Germany
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443739


Locations
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Germany
Charité
Berlin, Germany, 14109
Sponsors and Collaborators
Charite University, Berlin, Germany
Westfälische Wilhelms-Universität Münster
Investigators
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Principal Investigator: Andreas Michalsen, Prof. Dr. Charité University Medicine

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Responsible Party: Andreas Michalsen, Clinical professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03443739     History of Changes
Other Study ID Numbers: Bahá'í fast
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
Intermittent Fasting
Religious Fast
Bahá'í
Hydration
Calorimetry
Microdialysis
circadian clock
circadian rhythm
spirituality
self-efficacy