Physiological Response to 5 Days Fasting

Healthy Clinical Trial

Official title:

Physiological Response to Prolonged Fasting in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04452916
• Other study ID #: LEANER
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 31, 2024
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Buchinger fasting
Caloric intake of < 250 kcal/d for 5 days

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Energy Expenditure	Measured by indirect calorimetry (kcal/d)	6-th day of fasting compared to baseline
Secondary	Resting Energy Expenditure - Recovery	Measured by indirect calorimetry (kcal/d)	12 weeks after fasting compared to baseline
Secondary	Resting Respiratory Exchange Ratio	Measured by indirect calorimetry	6-th day of fasting and 28 days after fasting compared to baseline
Secondary	Office systolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Office diastolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Fecal microbiome composition	Measured by 16S Sequencing	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Fecal and serum metabolome	Measured by mass spectrometry	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Change in immune cell phenotypes	Peripheral blood effector T cell frequencies (Percent)	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Glucose variability	Measured by continuous glucose monitoring over 14 days	From 3 days before until 6 days after fasting
Secondary	Neural correlates of emotion processing	Measured by functional Magnetic Resonance Imaging	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Neural correlates of food-specific delay discounting	Measured by functional Magnetic Resonance Imaging	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Perceived Stress Questionaire (PSQ)	Range 0-100, with 0 indicating no perceived stress	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	Perceived Self Efficiency	Range 10-40, with 40 indicating highest self efficiency	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	PANAS Positive Affect Subscale (GESIS Panel)	Range 10-50, with 50 indicating highest positive affect	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	PANAS Negative Affect Subscale (GESIS Panel)	Range 10-50, with 50 indicating highest negative affect	6-th day of fasting and 12 weeks after fasting compared to baseline
Secondary	International Physical Activity Questionaire (IPAQ, long version)	Time for moderate and vigorous activity (hours, minutes)	6-th day of fasting and 12 weeks after fasting compared to baseline