Ascending Glycan Dietary Supplementation in Healthy Adults

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

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 Overview

• Status: Recruiting
• Conditions: Healthy Individuals
• Intervention / Treatment: Dietary supplement: Monosaccharide Powder; Other: Placebo Comparator

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Emanual Maverakis, MD; Phone Number: 916-551-2635; Email: emaverakis@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95630
      • Recruiting
      • University of California, Davis Medical Center
      • Contact: Lauren Downing; Phone Number: 916-551-2635; Email: dermtrials@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Cohort 1-4; 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; Monosaccharide powder dissolved in water.
Placebo Comparator: Placebo: Cohort 1-4; 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; Placebo (cellulose powder).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Emanual Maverakis, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Dietary supplements; Healthy Adults
• Other Study ID Numbers: 1516913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No