Physiological Response to 5 Days Fasting

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04452916
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Buchinger fasting	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Waiting list control groupWaiting list control group
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Physiological Response to Prolonged Fasting in Healthy Volunteers
• Actual Study Start Date: Nov 2, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fasting Starts immediately with 5 days of Buchinger fasting	Other: Buchinger fasting; Caloric intake of < 250 kcal/d for 5 days
Placebo Comparator: Waiting list control Starts with 5 days of Buchinger fasting after a waiting period of 12 weeks	Other: Buchinger fasting; Caloric intake of < 250 kcal/d for 5 days

Outcome Measures

Primary Outcome Measures

1. Resting Energy Expenditure [6-th day of fasting compared to baseline]

   Measured by indirect calorimetry (kcal/d)

Secondary Outcome Measures

1. Resting Energy Expenditure - Recovery [12 weeks after fasting compared to baseline]

   Measured by indirect calorimetry (kcal/d)

2. Resting Respiratory Exchange Ratio [6-th day of fasting and 28 days after fasting compared to baseline]

   Measured by indirect calorimetry

3. Office systolic blood pressure [6-th day of fasting and 12 weeks after fasting compared to baseline]

   Mean of five consecutive blood pressure measurements (mmHg)

4. Office diastolic blood pressure [6-th day of fasting and 12 weeks after fasting compared to baseline]

   Mean of five consecutive blood pressure measurements (mmHg)

5. Fecal microbiome composition [6-th day of fasting and 12 weeks after fasting compared to baseline]

   Measured by 16S Sequencing

6. Fecal and serum metabolome [6-th day of fasting and 12 weeks after fasting compared to baseline]

   Measured by mass spectrometry

7. Change in immune cell phenotypes [6-th day of fasting and 12 weeks after fasting compared to baseline]

   Peripheral blood effector T cell frequencies (Percent)

8. Glucose variability [From 3 days before until 6 days after fasting]

   Measured by continuous glucose monitoring over 14 days

9. Neural correlates of emotion processing [6-th day of fasting and 12 weeks after fasting compared to baseline]

   Measured by functional Magnetic Resonance Imaging

10. Neural correlates of food-specific delay discounting [6-th day of fasting and 12 weeks after fasting compared to baseline]

    Measured by functional Magnetic Resonance Imaging

11. Perceived Stress Questionaire (PSQ) [6-th day of fasting and 12 weeks after fasting compared to baseline]

    Range 0-100, with 0 indicating no perceived stress

12. Perceived Self Efficiency [6-th day of fasting and 12 weeks after fasting compared to baseline]

    Range 10-40, with 40 indicating highest self efficiency

13. PANAS Positive Affect Subscale (GESIS Panel) [6-th day of fasting and 12 weeks after fasting compared to baseline]

    Range 10-50, with 50 indicating highest positive affect

14. PANAS Negative Affect Subscale (GESIS Panel) [6-th day of fasting and 12 weeks after fasting compared to baseline]

    Range 10-50, with 50 indicating highest negative affect

15. International Physical Activity Questionaire (IPAQ, long version) [6-th day of fasting and 12 weeks after fasting compared to baseline]

    Time for moderate and vigorous activity (hours, minutes)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Universitätsmedizin Berlin	Berlin		Germany	13125

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Anja Mähler, PhD, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anja Maehler, Principal Investigator, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04452916
• Other Study ID Numbers: LEANER
• First Posted: Jul 1, 2020
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 8, 2022