Clinical trial NCT04452916: Physiological Response to 5 Days Fasting
Official title: Physiological Response to Prolonged Fasting in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waiting list control group
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate energy metabolism, anthropometry, blood pressure, gut microbiome, serum metabolome, glucose variability and neural mechanisms of food choice and mood before and after 5 days of fasting as well as their persistence in healthy men and women.


Eligibility criteria: Inclusion Criteria:

* Men and women
* 20-50 years
* Body mass index 20-30 kg/m2

Exclusion Criteria:

* Clinically relevant heart, lung, liver, and kidney diseases
* Any prescribed medication (except for oral contraceptives)
* Current or chronic infection
* Intake of antibiotics within 6 months before study entry
* Fasting week within 6 months before study entry
* Habitual use of dietary supplements
* Food intolerances
* Pregnancy, lactation
* Vegan diet
* Smokers
* In addition for fMRI: sensorineural hearing loss, tinnitus, metal implants, electric devices

Primary outcomes:
measure: Resting Energy Expenditure
timeFrame: 6-th day of fasting compared to baseline
Secondary outcomes:
measure: Resting Energy Expenditure - Recovery
timeFrame: 12 weeks after fasting compared to baseline
measure: Resting Respiratory Exchange Ratio
timeFrame: 6-th day of fasting and 28 days after fasting compared to baseline
measure: Office systolic blood pressure
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Office diastolic blood pressure
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Fecal microbiome composition
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Fecal and serum metabolome
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Change in immune cell phenotypes
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Glucose variability
timeFrame: From 3 days before until 6 days after fasting
measure: Neural correlates of emotion processing
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Neural correlates of food-specific delay discounting
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Perceived Stress Questionaire (PSQ)
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: Perceived Self Efficiency
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: PANAS Positive Affect Subscale (GESIS Panel)
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: PANAS Negative Affect Subscale (GESIS Panel)
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
measure: International Physical Activity Questionaire (IPAQ, long version)
timeFrame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Sylvia Bähring, PhD
role: PRINCIPAL_INVESTIGATOR
References: