Ascending Glycan Dietary Supplementation in Healthy Adults

Study Overview
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Brief Summary
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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).

Official Title
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Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults

Conditions
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Healthy Individuals

Intervention / Treatment
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* Dietary Supplement: Monosaccharide Powder
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria are placed to minimize variability in diet in our study population): Actively dieting or trying to lose weight Vegan diet Consume equal to or greater than 2 cups of tea a day Consume equal to or greater than 4 cups of coffee a day Consume equal to or greater than 3 cups of fruit juice a day Practice intensive exercise patterns (marathon training, workouts >4 hours a day) Consume soda or energy drinks of any amount On a carbohydrate-restricted or Paleo diet Calorie-restricted diet (less than 20%-25% of maintenance calories)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Cohort 1-4<br>60% of subjects per cohort will consume 30-90 grams of dietary supplement daily for 4 weeks, with each successive cohort dosage increasing according to a Fibonacci dose escalation. | Dietary Supplement: Monosaccharide Powder<br>* Monosaccharide powder dissolved in water.<br>|
| Placebo Comparator: Placebo: Cohort 1-4<br>40% of subjects per cohort will consume 30-90 grams of daily placebo for 4 weeks with each successive cohort dosage increasing in parallel to the experimental arm. | Other: Placebo Comparator<br>* Placebo (cellulose powder).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 Weeks | 
| Identify the maximum effective dose | Identify maximum effective dose of dietary supplement in grams/day. | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess for potential adverse events | Monitor symptoms, severity, and duration of adverse events. | 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. | 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). | 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. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary supplements, Healthy Adults