Immunomodulatory Effects of Fasting in Healthy Adults

NCT05104502 | Recruiting

• 1 other identifier: 1816627
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Changes in peripheral blood mononuclear cells

  Changes in surface proteins and glycoproteins of peripheral blood mononuclear cells

  7 months

Study Arms (1)

Fasting

EXPERIMENTAL

Dietary fasting.

Behavioral: Dietary Fasting

Interventions

Dietary Fasting BEHAVIORAL

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).

Fasting

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 birth control including oral contraception pills, hormonal IUDs or rings, or hormonal birth control patches

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Antonio Ji

CONTACT

916-551-2630; ajixu@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: March 25, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)