FastingNCT06779201
Fasting Effects on Metabolism and Immunity Study in Human
A study testing Fasting in people with Fasting, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, gender is not limited;
- BMI≥18.5;
- Can tolerate a certain degree of hunger;
- Can voluntarily sign written informed consent.
Who cannot join
- Women planning pregnancy, pregnancy and breastfeeding;
- Previous liver disease, chronic kidney disease, heart disease and cerebrovascular disease;
- Suffering from acute infectious diseases or chronic wasting diseases;
- Have used antibiotic drugs in the past 3 months, and have used prebiotic or probiotic supplements or products in the past month;
- Participate in other clinical investigators within 3 months before enrollment in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Hongxing Wang, MD & PhD, 01083198650, hxwang8888@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fasting
- Being tested
- Fasting
- Keywords
- Fasting, Metabolism, Immunity, Brain function, Intestinal flora
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
One-week fasting without limit of water drink (Participants can feel free to drink water )
| Study group | Role | What they receive |
|---|---|---|
| Adults who can tolerate a certain degree of hunger | Experimental | The subjects will undergo a complete fast for one week (water is allowed). Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of cytokine levels in subjects' blood (and/or urine/stool) samples from T1 to T2, T3, T4, and T5.
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.
Measured: 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.
Metabolites measured include metabolic levels of amino acids, short-chain fatty acids, steroid hormones, fat-soluble vitamins, and other substances.
Measured: 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 outcomes (7)
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.
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.
Measured: 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.
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.
Measured: 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.
Lipids measured include total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, Apolipoprotein A, and Apolipoprotein B.
Measured: 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
Measured: 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.
Measured: 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.
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).
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Sep 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongxing Wang, MD & PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779201
- Sponsor's protocol ID
- fasting
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect and Mechanism of Fasting on Human Metabolism and Immunity
- ClinicalTrials.gov ID
- NCT06779201
- Acronym / sponsor ID
- fasting
- Conditions
- Fasting
- Keywords
- Fasting, Metabolism, Immunity, Brain function, Intestinal flora
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults who can tolerate a certain degree of hunger | Experimental | Other: FastingThe subjects will undergo a complete fast for one week (water is allowed). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years old, gender is not limited;
- BMI≥18.5;
- Can tolerate a certain degree of hunger;
- Can voluntarily sign written informed consent.
Key exclusion criteria (5 listed)
- Women planning pregnancy, pregnancy and breastfeeding;
- Previous liver disease, chronic kidney disease, heart disease and cerebrovascular disease;
- Suffering from acute infectious diseases or chronic wasting diseases;
- Have used antibiotic drugs in the past 3 months, and have used prebiotic or probiotic supplements or products in the past month;
- Participate in other clinical investigators within 3 months before enrollment in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingOne-week fasting without limit of water drink (Participants can feel free to drink water ) | Other | Adults who can tolerate a certain degree of hunger |
Primary outcome
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.
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.
7 secondary outcomes
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.
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 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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongxing Wang, MD & PhD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Fasting, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Li, MD (+86 10 83198650, ruili@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.