RecruitingNot ApplicableNCT05104502

Immunomodulatory Effects of Fasting in Healthy Adults

Sponsor

University of California, Davis

Enrollment

4 participants

Start Date

Mar 25, 2022

Study Type

INTERVENTIONAL

Conditions

Fasting

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.

Eligibility

Min Age: 20 YearsMax Age: 40 Years

Inclusion Criteria8

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.

Exclusion Criteria11

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

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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).