Healthy
Conditions
Keywords
dietary supplement
Brief summary
Two randomized double-blind placebo-controlled clinical studies to assess the effects of dietary glycan monomer supplementation on the immune system, especially antibody glycosylation in healthy adults. Immune profiling and glycoproteomics will be performed on serum isolated at these same time points.
Interventions
DIETARY_SUPPLEMENTMonosaccharide Powder
Monosaccharide powder dissolved in water.
DIETARY_SUPPLEMENTPlacebo Comparator
Placebo (glucose powder)
Sponsors
University of California, Davis
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25
Exclusion criteria
* Adults younger than 18 or older than 45 years of age * Women who are pregnant, actively nursing or have had a pregnancy within the last year * Women who are peri-menopausal or post-menopausal * Women with irregular menstrual cycles (more frequently than every 21 days or lasts longer than 8 days. Missed, early, or late periods are also considered signs of an irregular cycle) * Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant * Individuals with past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer * Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any type * Individuals with diagnosis of galactosemia or congenital disorders of glycosylation * Individuals with phenylketonuria * Individuals currently taking prescription medications, or who have taken prescription medications within the last 3 months * Individuals currently taking over-the-counter medications * Individuals currently taking or who have taken supplements including herbal, protein or vitamin supplements in the last 3 months (e.g. whey protein, St. John's Wort, green tea supplements, biotin, creatine supplements), excluding multivitamins or essential vitamins * Individuals with BMI less than 18.5 or greater than 25 * Individuals with prior history of severe food or drug allergic reactions * Individuals with allergic reaction or adverse reaction to shellfish, N-acetylglucosamine, galactose, Spirulina/chlorella/algae supplements, or arabinose containing compounds/foods/supplements * Individuals with first-degree relative with history of an autoimmune condition * Individuals with social history of current use of tobacco, alcohol or other drugs * Individuals with dietary restrictions (vegetarians are permitted to participate in the study) or atypical exercise patterns, or to whom any of the following dietary habits or characteristics apply (the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize Immunoglobulin fragment crystallization modifications | 4 Weeks | Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess for potential adverse events | 2 months after first dose | Monitor symptoms, severity, and duration of adverse events. |
| Quantification of enzymatic modifications measured in grams by spectrometry | 6 months | 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. |
| Flow cytometry to determine the effect of dietary supplementation on the immune system | 6 months | 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). |
| Transcriptome analysis to determine the effect of dietary supplementation on the immune system | 6 months | 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. |
Countries
United States
Contacts
CONTACTEmanual Maverakis, MD
PRINCIPAL_INVESTIGATOREmanual Maverakis, MD
University of California, Davis
Outcome results
None listed