The Effects of Dietary Supplementation on Serum Protein Glycosylation

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Sep 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how a dietary supplement made from glycan monomers (a type of sugar) affects the immune system, particularly how it influences the glycosylation of antibodies in healthy adults. Glycosylation is a process that helps antibodies function properly, and this research aims to understand if taking this supplement can improve immune responses. The trial is part of a Phase 1 study, meaning it’s in the early stages of testing its safety and effectiveness.

To be eligible for the trial, participants must be healthy adults aged 18 to 45 with a Body Mass Index (BMI) between 18.5 and 25. Unfortunately, individuals who are pregnant, nursing, or have certain health conditions, such as autoimmune diseases, cannot participate. Participants will be randomly assigned to receive either the supplement or a placebo (a harmless pill with no active ingredients) without knowing which one they are getting. Throughout the study, they will have blood tests to monitor changes in their immune system and glycosylation. This trial is currently recruiting participants, so if you meet the criteria and are interested, it could be a chance to contribute to important research!

Gender

ALL

Eligibility criteria

• 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