Healthy Individuals
Conditions
Keywords
Healthy Adults, Dietary supplements
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTMonosaccharide Powder
Monosaccharide powder dissolved in water.
OTHERPlacebo Comparator
Placebo (cellulose powder).
Sponsors
University of California, Davis
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
* Patients must be 18-45 years of age * Patients who are in general good health * Body Mass Index (BMI) range of 18.5-25 * All individuals must have the ability to provide inform consent
Exclusion criteria
* Women who are pregnant, actively nursing, or pregnant 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 * Past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer * Individuals with first degree relative with history of an autoimmune condition * Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any kind * Individuals with diagnosis of galactosemia or congenital disorders of glycosylation * Individuals with phenylketonuria * Individuals currently taking prescription medications, or have taken prescription medications within the last 3 months * Individuals currently taking over the counter medications * Individuals currently taking or 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 prior history of severe food or drug allergic reactions * Individuals with a diagnosis of type I or II diabetes mellitus * Individuals with allergic reaction or adverse reaction to shellfish, N-acetyl glucosamine, galactose, or Spirulina/chlorella/algae supplements * 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 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. |
| Identify the maximum effective dose | 16 Weeks | Identify maximum effective dose of dietary supplement in grams/day. |
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
Outcome results
None listed