Fasting Effects on Metabolism and Immunity Study in Human

January 19, 2025 updated by: Xuanwu Hospital, Beijing

Study on the Effect and Mechanism of Fasting on Human Metabolism and Immunity

This study aims to investigate the effects of 1-week fasting but not prohibiting water drink on human immune function, metabolic indicators, and brain function in human, and to explore the underlying mechanisms of these changes from a multi-omics perspective and/or other ways.

Study Overview

Status

Status

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

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.

Detailed Description

As a historic practice, fasting has a place in religion, culture and modern medicine. In recent years, studies have found that moderate food interruption can positively affect metabolism, immunity, and brain function. It can promote cellular autophagy, improve insulin sensitivity, reduce inflammation, and may protect brain health. Intermittent fasting is thought to improve metabolic health, reduce the risk of obesity and type 2 diabetes, and promote cellular self-repair by regulating signaling pathways. Food fasting also improves insulin sensitivity, reduces blood glucose, reduces inflammatory markers, and improves fat oxidation rate, contributing in the prevention and treatment of metabolic diseases. Moreover, food fasting can regulate immune cell function, reduce chronic inflammation, and may regulate immune function by affecting gut microbiota diversity. In terms of brain function, fasting may improve cognitive function by promoting neuroplasticity and enhancing neuroprotective mechanisms. However, most of the existing studies focus on animal experiments, lack large-scale human clinical trials, and the mechanism of feeding is not completely clear. This study will explore the effects of complete fasting for 1 week (but can feel free to drink water) on human immune function, metabolic indicators and brain function in human, and analyze its change mechanism from a multi-omics perspective and/or other ways, so as to provide new data support for understanding the biological mechanism of fasting, and promote its application in disease prevention and treatment.

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 (Estimated)

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.
30

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18-65 years old, gender is not limited;
  2. BMI≥18.5;
  3. Can tolerate a certain degree of hunger;
  4. Can voluntarily sign written informed consent.

Exclusion Criteria:

  1. Women planning pregnancy, pregnancy and breastfeeding;
  2. Previous liver disease, chronic kidney disease, heart disease and cerebrovascular disease;
  3. Suffering from acute infectious diseases or chronic wasting diseases;
  4. Have used antibiotic drugs in the past 3 months, and have used prebiotic or probiotic supplements or products in the past month;
  5. Participate in other clinical investigators within 3 months before enrollment in this study.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group 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.
Experimental: Adults who can tolerate a certain degree of hunger
The subjects will undergo a complete fast for one week (water is allowed).
Other: Fasting
One-week fasting without limit of water drink (Participants can feel free to drink water )

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
The change of cytokine levels in subjects' blood (and/or urine/stool) samples from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
Cytokines measured included pro-inflammatory cytokines such as IL-1β, IL-6, and TNF-α, as well as anti-inflammatory cytokines such as IL-10 and TGF-β.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The change of metabolite levels in subjects' blood (and/or urine/stool) samples from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
Metabolites measured include metabolic levels of amino acids, short-chain fatty acids, steroid hormones, fat-soluble vitamins, and other substances.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.

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
The change in concentration of intestinal flora species，rate of change in bacterial diversity，abundance of functional genes in subjects' stool samples from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
Measure the concentration of specific bacterial species, e.g., relative and absolute abundance of Thick-walled phylum, Mycobacterium phylum, etc.; assess the rate of change in the diversity of the bacterial community, including α-diversity and β-diversity.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The change of brain function from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The effects of fasting on brain function were assessed by resting-state functional magnetic resonance imaging (rs-fMRI) and diffusion tensor imaging (DTI) for local coherence (ReHo) and low-frequency amplitude (ALFF), which were used to assess changes in functional brain activity. Fraction of anisotropy (FA), axial dispersion (AD), radial dispersion (RD), and mean dispersion (MD), were used to assess the structural integrity of cerebral white matter.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The change of blood lipid levels from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
Lipids measured include total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, Apolipoprotein A, and Apolipoprotein B.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The change of homocysteine levels from T1 to T2, T3, T4, and T5
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The change of insulin levels in subjects' blood samples from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The change of thyroid function level from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
Thyroid function indicators measured include thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), total triiodothyronine (TT3), total thyroxine (TT4), antithyroid peroxidase antibody (TPOAb), antithyroglobulin antibody (TGAb), and thyrotropin receptor antibody (TRAb).
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
The change of body fat percentage from T1 to T2, T3, T4, and T5.
Time Frame: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.
T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.

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.
Xuanwu Hospital, Beijing

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: Hongxing Wang, MD & PhD, Xuanwu Hospital, Beijing

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.
September 1, 2024

Primary Completion (Estimated)

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.
October 31, 2027

Study Completion (Estimated)

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.
December 31, 2027

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).
January 5, 2025

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.
January 12, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
January 19, 2025

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.
January 1, 2025

More Information

Terms related to this study

Keywords

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.
  • fasting

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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