Physiological Response to 5 Days Fasting

August 19, 2024 updated by: Sylvia Bähring, PhD, Charite University, Berlin, Germany

Physiological Response to Prolonged Fasting in Healthy Volunteers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resting Energy Expenditure
Time Frame: 6-th day of fasting compared to baseline
Measured by indirect calorimetry (kcal/d)
6-th day of fasting compared to baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting Energy Expenditure - Recovery
Time Frame: 12 weeks after fasting compared to baseline
Measured by indirect calorimetry (kcal/d)
12 weeks after fasting compared to baseline
Resting Respiratory Exchange Ratio
Time Frame: 6-th day of fasting and 28 days after fasting compared to baseline
Measured by indirect calorimetry
6-th day of fasting and 28 days after fasting compared to baseline
Office systolic blood pressure
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Mean of five consecutive blood pressure measurements (mmHg)
6-th day of fasting and 12 weeks after fasting compared to baseline
Office diastolic blood pressure
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Mean of five consecutive blood pressure measurements (mmHg)
6-th day of fasting and 12 weeks after fasting compared to baseline
Fecal microbiome composition
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Measured by 16S Sequencing
6-th day of fasting and 12 weeks after fasting compared to baseline
Fecal and serum metabolome
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Measured by mass spectrometry
6-th day of fasting and 12 weeks after fasting compared to baseline
Change in immune cell phenotypes
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Peripheral blood effector T cell frequencies (Percent)
6-th day of fasting and 12 weeks after fasting compared to baseline
Glucose variability
Time Frame: From 3 days before until 6 days after fasting
Measured by continuous glucose monitoring over 14 days
From 3 days before until 6 days after fasting
Neural correlates of emotion processing
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Measured by functional Magnetic Resonance Imaging
6-th day of fasting and 12 weeks after fasting compared to baseline
Neural correlates of food-specific delay discounting
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Measured by functional Magnetic Resonance Imaging
6-th day of fasting and 12 weeks after fasting compared to baseline
Perceived Stress Questionaire (PSQ)
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Range 0-100, with 0 indicating no perceived stress
6-th day of fasting and 12 weeks after fasting compared to baseline
Perceived Self Efficiency
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Range 10-40, with 40 indicating highest self efficiency
6-th day of fasting and 12 weeks after fasting compared to baseline
PANAS Positive Affect Subscale (GESIS Panel)
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Range 10-50, with 50 indicating highest positive affect
6-th day of fasting and 12 weeks after fasting compared to baseline
PANAS Negative Affect Subscale (GESIS Panel)
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Range 10-50, with 50 indicating highest negative affect
6-th day of fasting and 12 weeks after fasting compared to baseline
International Physical Activity Questionaire (IPAQ, long version)
Time Frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
Time for moderate and vigorous activity (hours, minutes)
6-th day of fasting and 12 weeks after fasting compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sylvia Bähring, PhD, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LEANER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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