The investigators will conduct a parallel-group, placebo-controlled, randomized, double-blind ascending dose Phase I study of dietary supplementation in healthy individuals to evaluate safety and to determine the pharmacologically effective dose (ED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
14
Monosaccharide powder dissolved in water.
Placebo (cellulose powder).
University of California, Davis Medical Center
Sacramento, California, United States
Characterize Immunoglobulin fragment crystallization modifications
Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G.
Time frame: 4 Weeks
Identify the maximum effective dose
Identify maximum effective dose of dietary supplement in grams/day.
Time frame: 16 Weeks
Assess for potential adverse events
Monitor symptoms, severity, and duration of adverse events.
Time frame: 2 Months after first dose
Quantification of enzymatic modifications measured in grams by spectrometry
The investigators will measure enzymatic changes on glycoproteins in the immune system by spectrometry, i.e., these changes will be measured in grams. Spectometry will allow the investigators to quantify these changes in small detail, and therefore give a better idea of how supplementation can change enzymatic process that then affect the structure, and mass, of glycoproteins.
Time frame: 6 Months
Flow cytometry to determine the effect of dietary supplementation on the immune system
Perform flow cytometry on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as translated proteins (measured as height and area of cytokine intensity).
Time frame: 6 Months
Transcriptome analysis to determine the effect of dietary supplementation on the immune system
Perform transcriptome analysis on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as RNA (measure on a logarithmic scale per number of reads) to determine the effects of supplementation on both gene transcription and translation.
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Time frame: 6 Months