ClinicalTrials.gg
RecruitingNCT05104502Updated Jul 6, 2026

Immunomodulatory Effects of Fasting in Healthy Adults

An interventional study of Dietary Fasting in Fasting, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Fasting

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03

In context

Fasting

392 studies on the registry are indexed under Fasting; 63 are open to participants now.

This study's planned enrollment of 4 is below the median of 45 across 311 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 20-40 years, to constitute a young study population
  • Gender: male subjects, to control for gender differences
  • : 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 including oral contraception pills, hormonal IUDs or rings, or hormonal birth control patches
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • Experimental
    Fasting

    Dietary fasting.

    Behavioral: Dietary Fasting

Interventions

  • BehavioralDietary Fasting

    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).

06

What researchers measure

Primary outcomes

  1. Changes in peripheral blood mononuclear cells

    Changes in surface proteins and glycoproteins of peripheral blood mononuclear cells

    Time frame: 7 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05104502
Responsible party
Sponsor
First posted
Nov 3, 2021
Start date
Mar 25, 2022
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jul 6, 2026

Study contacts

Antonio Ji
Contact
ajixu@ucdavis.edu
916-551-2630

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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