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Completed

NCT Number: NCT03443739

Effects of Fasting in the Bahá'í Faith

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité

Berlin, 14109, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermittent fasting

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Universität Münster

Registry information

Official study title

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

Acronym: BF

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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