Ascending Glycan Dietary Supplementation in Healthy Adults

NCT04466761 | Terminated Phase 1

• 1 other identifier: 1516913
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Individuals

Keywords

Healthy Adults; Dietary supplements

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Assess for potential adverse events

  2 Months after first dose

• Quantification of enzymatic modifications measured in grams by spectrometry

  6 Months

• Flow cytometry to determine the effect of dietary supplementation on the immune system

  6 Months

• Transcriptome analysis to determine the effect of dietary supplementation on the immune system

  6 Months

Study Arms (2)

Experimental: Cohort 1-4

EXPERIMENTAL

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

Placebo: Cohort 1-4

PLACEBO COMPARATOR

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

Interventions

Monosaccharide Powder DIETARY_SUPPLEMENT

Monosaccharide powder dissolved in water.

Experimental: Cohort 1-4

Placebo Comparator OTHER

Placebo (cellulose powder).

Placebo: Cohort 1-4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95630, United States

Location

Study Officials

• Emanual Maverakis, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 10, 2020
• Study Start: June 23, 2022
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)