FastingNCT05104502
Immunomodulatory Effects of Fasting in Healthy Adults
A study testing Dietary Fasting in people with Fasting, run by University of California, Davis at 1 site in United States.
Trial summary
This is a clinical trial assessing the effects of fasting on the immune system in healthy adults. Immune profiling, gene expression profiling, and flow cytometry on peripheral blood mononuclear cells (PBMCs) will be performed and we hypothesize that a period of fasting will alter the immune system in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Dietary Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2022to Sep 2026
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-40 years, to constitute a young study population
- Gender: male subjects, to control for gender differences
- BMI: 19-27 kg/m2 to constitute a normal/healthy weight population
- Weight: 120 lbs or more
- Fasting glucose: 70-100 mg/dL, to ensure that fasting can be tolerated without inducing dangerously low levels of blood glucose
- Subjects must be willing to undergo a period of 36 hours of water-only fasting
- Subjects must be willing to collect samples of each bowel movement produced throughout the entire study period for microbiome analysis
- Subjects must be willing to collect blood pricks for blood glucose levels using a Contour Next One Blood Glucose Testing Kit during the fasting stage of the study protocol.
Who cannot join
- Current smoking
- Anemia
- Pregnancy or current breastfeeding
- Chronic diseases including diabetes mellitus, thyroid disease, metabolic syndrome, cancer, or previous cardiovascular events
- Gastrointestinal diseases including irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease
- Consumption of >1 alcoholic drink/day
Show all 11Show fewer
- Extreme dietary or exercise patterns
- Recent weight fluctuations (greater than 10% in the last six months)
- Regular use of over-the-counter allergy or pain medications (>1/week)
- Taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones
- Use of hormonal birth control including oral contraception pills, hormonal IUDs or rings, or hormonal birth control patches
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis
Sacramento, California, 95816
Antonio Ji-Xu
About this study
This is a clinical trial assessing the effects of fasting on the immune system in healthy adults. Immune profiling, gene expression profiling, and flow cytometry on peripheral blood mononuclear cells (PBMCs) will be performed and we hypothesize that a period of fasting will alter the immune system in healthy adults.
Read the detailed description
Dietary restriction (DR) is an intervention demonstrated to increase healthy lifespan in various model organisms including yeast, worms, mice, and rhesus monkeys (Lee et al., 2016, Fontana et al., 2015). It has been investigated extensively as a therapeutic modality in metabolic disease such as hypertension, cardiovascular disease, and obesity, with evidence of benefit independent of weight loss (Wilkinson et al., 2020, Zhu et al., 2020, Di Francesco et al., 2018). The major DR regimens include caloric restriction (CR) (Fontana et al., 2010), time-restricted feeding (TRF) (Brandhorst et al., 2015), fasting mimicking diets (FMD) (Mirzaei et al., 2014), and intermittent fasting (IF) (Chaix et al., 2014). Within the broader, poorly defined concept of IF, specific regimens exist that have yet to be standardized, including alternate-day fasting (ADF), 5:2 intermittent fasting (fasting 2 days per week), and daily TRF (typically restricting eating to an 8 hour window with 16 hours of fasting) (Chaix et al., 2014, Stekovic et al., 2019).
Studies of the effects of several different forms of DR on the immune system have shown both pro- and anti-inflammatory effects on immune responses, particularly with chronic calorie restriction (Choi et al., 2017). Certain periodic dietary restrictions prevent immune dysfunction and restore normal immune functioning by decreasing the number of circulating autoimmune cells from circulation and activating tissue regenerative capacity (Cheng et al., 2014). Although both chronic CR and nutrient-restricted FMD require substantial lifestyle modifications and can prove challenging in terms of adherence, forms of TRF and IF provide reasonable alternatives while showing similar efficacy. This makes forms of DR involving fasting rather than CR more appealing as a clinical intervention.
While multiple studies have shown positive effects on the immune system with various IF regimens in the setting of rheumatoid arthritis (Müller et al., 2001), multiple sclerosis, and cancer, mechanistic data in healthy humans are lacking. Recent studies have demonstrated changes in immune cell distribution with various regimens of CR and IF in murine models, supporting the exploration of potentially similar changes in healthy humans (Nagai et al. 2019). In order to study mechanistic details of the immune changes seen with DR in healthy humans, we designed this trial to examine the effects of fasting dose on multiple immune cell populations and relevant cell surface markers. While we observe a cohort over what is effectively only a single cycle of ADF, here we make an important step in characterizing the immune modulation occurring with ADF. This is one of the most studied fasting regimens, with substantial possibility for use as a clinical therapy in the future.
- Conditions
- Fasting
- Being tested
- Dietary Fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary FastingBehavioural
The study will consist of two days of eating a "controlled habitual diet" and one 36-hour period of water-only fasting with glucose monitoring as a measure of compliance. Water intake will be limited to 2 liters/day to prevent electrolyte abnormalities. Subjects will undergo 4 separate blood-draws consisting of an overnight fasted sample (Baseline), a 2-hour postprandial sample (Fed), a 36-hour fasted sample (Fasted), and final 2-hour postprandial sample after the fasting period (Refed).
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Dietary fasting. Receives: Behavioral: Dietary Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral blood mononuclear cells
Changes in surface proteins and glycoproteins of peripheral blood mononuclear cells
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start25 Mar 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104502
- Sponsor's protocol ID
- 1816627
- Status last verified
- Jul 2026
- First submitted
- 22 Oct 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effects of Fasting in Healthy Adults
- ClinicalTrials.gov ID
- NCT05104502
- Acronym / sponsor ID
- 1816627
- Conditions
- Fasting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Nov 2021 (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 is a clinical trial assessing the effects of fasting on the immune system in healthy adults. Immune profiling, gene expression profiling, and flow cytometry on peripheral blood mononuclear cells (PBMCs) will be performed and we hypothesize that a period of fasting will alter the immune system in healthy adults.
Detailed description
Dietary restriction (DR) is an intervention demonstrated to increase healthy lifespan in various model organisms including yeast, worms, mice, and rhesus monkeys (Lee et al., 2016, Fontana et al., 2015). It has been investigated extensively as a therapeutic modality in metabolic disease such as hypertension, cardiovascular disease, and obesity, with evidence of benefit independent of weight loss (Wilkinson et al., 2020, Zhu et al., 2020, Di Francesco et al., 2018). The major DR regimens include caloric restriction (CR) (Fontana et al., 2010), time-restricted feeding (TRF) (Brandhorst et al., 2015), fasting mimicking diets (FMD) (Mirzaei et al., 2014), and intermittent fasting (IF) (Chaix et al., 2014). Within the broader, poorly defined concept of IF, specific regimens exist that have yet to be standardized, including alternate-day fasting (ADF), 5:2 intermittent fasting (fasting 2 days per week), and daily TRF (typically restricting eating to an 8 hour window with 16 hours of fasting) (Chaix et al., 2014, Stekovic et al., 2019).
Studies of the effects of several different forms of DR on the immune system have shown both pro- and anti-inflammatory effects on immune responses, particularly with chronic calorie restriction (Choi et al., 2017). Certain periodic dietary restrictions prevent immune dysfunction and restore normal immune functioning by decreasing the number of circulating autoimmune cells from circulation and activating tissue regenerative capacity (Cheng et al., 2014). Although both chronic CR and nutrient-restricted FMD require substantial lifestyle modifications and can prove challenging in terms of adherence, forms of TRF and IF provide reasonable alternatives while showing similar efficacy. This makes forms of DR involving fasting rather than CR more appealing as a clinical intervention.
While multiple studies have shown positive effects on the immune system with various IF regimens in the setting of rheumatoid arthritis (Müller et al., 2001), multiple sclerosis, and cancer, mechanistic data in healthy humans are lacking. Recent studies have demonstrated changes in immune cell distribution with various regimens of CR and IF in murine models, supporting the exploration of potentially similar changes in healthy humans (Nagai et al. 2019). In order to study mechanistic details of the immune changes seen with DR in healthy humans, we designed this trial to examine the effects of fasting dose on multiple immune cell populations and relevant cell surface markers. While we observe a cohort over what is effectively only a single cycle of ADF, here we make an important step in characterizing the immune modulation occurring with ADF. This is one of the most studied fasting regimens, with substantial possibility for use as a clinical therapy in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Behavioral: Dietary FastingDietary fasting. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 20-40 years, to constitute a young study population
- Gender: male subjects, to control for gender differences
- BMI: 19-27 kg/m2 to constitute a normal/healthy weight population
- Weight: 120 lbs or more
- Fasting glucose: 70-100 mg/dL, to ensure that fasting can be tolerated without inducing dangerously low levels of blood glucose
Key exclusion criteria (11 listed)
- Current smoking
- Anemia
- Pregnancy or current breastfeeding
- Chronic diseases including diabetes mellitus, thyroid disease, metabolic syndrome, cancer, or previous cardiovascular events
- Gastrointestinal diseases including irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease
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 |
|---|---|---|
| Dietary FastingThe study will consist of two days of eating a "controlled habitual diet" and one 36-hour period of water-only fasting with glucose monitoring as a measure of compliance. Water intake will be limited to 2 liters/day to prevent electrolyte abnormalities. Subjects will undergo 4 separate blood-draws consisting of an overnight fasted sample (Baseline), a 2-hour postprandial sample (Fed), a 36-hour fasted sample (Fasted), and final 2-hour postprandial sample after the fasting period (Refed). | Behavioural | Fasting |
Primary outcome
Changes in peripheral blood mononuclear cells
Time frame: 7 months
Changes in surface proteins and glycoproteins of peripheral blood mononuclear cells
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 6 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fasting in people with Fasting, run by University of California, Davis at 1 site in United States.
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 8 inclusion and 11 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 6 Jul 2026. 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 United States. 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 Antonio Ji (916-551-2630, ajixu@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peripheral blood mononuclear cells (time frame: 7 months). 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 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.