BF: Effects of Fasting in the Bahá'í Faith

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT03443739

Collaborator

Westfälische Wilhelms-Universität Münster (Other)

145

Enrollment

Location

17.3

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Feb 19, 2018

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Jul 31, 2019

Outcome Measures

Primary Outcome Measures

Serum Osmolarity [12 hours]
Measured in subsample of study participants (venous blood sample) osmol/l
In 2019: Validation of new questionnaire [1 hour]
New questionnaire, developed in 2018, regarding Bahai fasting

Secondary Outcome Measures

Urine Osmolality [24 hours]
Measured in subsample of participants, in spontaneous Urine sample and 12h/24h Urine samples osmol/kg
Acid-base balance [5 Minutes]
Measured in subsample of study participants (venous blood sample) Measured with Radiometer, Base excess (mmol/l)

Other Outcome Measures

Questionnaire: HADS (Hospital Anxiety and Depression Score) [5 Minutes]
Anxiety and depression
Systolic and diastolic blood pressure [5 Minutes]
Measured in subsample of study participants Measured by clinician, mmHg
BMI [10 Minutes]
Measured in subsample of study participants Quantitative, kg/m2
Microdialysis [3 hours]
Measured in subsample of study participants
Indirect calorimetry [2 hours]
Measured in subsample of study participants
Individual Interview [30 Minutes, three times during study]
Measured in subsample of study participants
Activation of clock genes [3 Minutes]
Measured in subsample of study participants Measured in monocytes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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