Physiological Response to 5 Days Fasting

NCT04452916 | Completed

• 1 other identifier: LEANER
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Resting Energy Expenditure

  Measured by indirect calorimetry (kcal/d)

  6-th day of fasting compared to baseline

Secondary Outcomes (15)

• Resting Energy Expenditure - Recovery

  12 weeks after fasting compared to baseline

• Resting Respiratory Exchange Ratio

  6-th day of fasting and 28 days after fasting compared to baseline

• Office systolic blood pressure

  6-th day of fasting and 12 weeks after fasting compared to baseline

• Office diastolic blood pressure

  6-th day of fasting and 12 weeks after fasting compared to baseline

• Fecal microbiome composition

  6-th day of fasting and 12 weeks after fasting compared to baseline

Study Arms (2)

Fasting

ACTIVE COMPARATOR

Starts immediately with 5 days of Buchinger fasting

Other: Buchinger fasting

Waiting list control

PLACEBO COMPARATOR

Starts with 5 days of Buchinger fasting after a waiting period of 12 weeks

Other: Buchinger fasting

Interventions

Buchinger fasting OTHER

Caloric intake of \< 250 kcal/d for 5 days

Fasting; Waiting list control

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 13125, Germany

Location

Study Officials

• Sylvia Bähring, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Waiting list control group

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 1, 2020
• Study Start: November 2, 2020
• Primary Completion: December 14, 2022
• Study Completion: July 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DE (1)