The Effects of Dietary Supplementation on Serum Protein Glycosylation

NCT05040204 | Recruiting Phase 1

• 2 other identifiers: 9492211K24AR077313-01A1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

dietary supplement

Outcome Measures

Primary Outcomes (1)

• 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

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 (5)

Experimental Supplement 1

EXPERIMENTAL

6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks

Dietary Supplement: Monosaccharide Powder

Experimental Supplement 2

EXPERIMENTAL

6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks

Dietary Supplement: Monosaccharide Powder

Experimental Supplement 3

EXPERIMENTAL

20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks

Dietary Supplement: Monosaccharide Powder

Placebo Comparator 1

PLACEBO COMPARATOR

6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks

Dietary Supplement: Placebo Comparator

Placebo Comparator 2

PLACEBO COMPARATOR

6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks

Dietary Supplement: Placebo Comparator

Interventions

Monosaccharide Powder DIETARY_SUPPLEMENT

Monosaccharide powder dissolved in water.

Experimental Supplement 1; Experimental Supplement 2; Experimental Supplement 3

Placebo Comparator DIETARY_SUPPLEMENT

Placebo (glucose powder)

Placebo Comparator 1; Placebo Comparator 2

Eligibility Criteria

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

You may qualify if:

• Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95816, United States

RECRUITING

Related Links

• Learn more or sign up for the study here!

Study Officials

• Emanual Maverakis, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanual Maverakis, MD

CONTACT

916-551-2635; emaverakis@ucdavis.edu

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: September 1, 2021
• First Posted: September 10, 2021
• Study Start: June 23, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)