The Effects of Dietary Supplementation on Serum Protein Glycosylation

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo Comparator; Dietary Supplement: Monosaccharide Powder

• Registration Number: NCT05040204
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-10
• Study Start: 2022-06-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-05-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

• 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

• Individuals with first-degree relative with history of an autoimmune condition

• 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 atypical exercise patterns, or to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet/exercise patterns in our pilot 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

• Consume fast food equal to or greater than 5 days per week

• Consume greater than one serving of alcohol per day

  • (1 serving of wine = 6 oz, 1 serving of beer = 12 oz, 1 serving of spirits = 1 oz)

• On a carbohydrate-restricted or "Paleo" diet, or calorie-restricted diet (less than 20-25% of maintenance calories)

• Adults unable to consent

• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator 1	Placebo Comparator	6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks
Experimental Supplement 2	Monosaccharide Powder	6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks
Experimental Supplement 1	Monosaccharide Powder	6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks
Experimental Supplement 3	Monosaccharide Powder	20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks
Placebo Comparator 2	Placebo Comparator	6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
Assess for potential adverse events	2 months after first dose	Monitor symptoms, severity, and duration of adverse events.
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).

Trial Locations

Locations (1)

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States