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临床试验/NCT03443739
NCT03443739已完成不适用

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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2018年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
1
主要终点
Serum Osmolarity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Serum Osmolarity

时间窗: 12 hours

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

In 2019: Validation of new questionnaire

时间窗: 1 hour

New questionnaire, developed in 2018, regarding Bahai fasting

次要结局

  • Urine Osmolality(24 hours)
  • Acid-base balance(5 Minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Michalsen

Clinical professor

Charite University, Berlin, Germany

研究点 (1)

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