NCT05040204 The Effects of Dietary Supplementation on Serum Protein Glycosylation
| NCT ID | NCT05040204 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, Davis |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2022-06-23 |
| Primary Completion | 2026-11-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 44 participants in total. It began in 2022-06-23 with a primary completion date of 2026-11-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Emanual Maverakis, MD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT05040204 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05040204 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05040204 currently recruiting?
Yes, NCT05040204 is actively recruiting participants. Contact the research team at emaverakis@ucdavis.edu for enrollment information.
Where is the NCT05040204 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT05040204 clinical trial?
NCT05040204 is sponsored by University of California, Davis. The principal investigator is Emanual Maverakis, MD at University of California, Davis. The trial plans to enroll 44 participants.