RecruitingPhase 1

The Effects of Dietary Supplementation on Serum Protein Glycosylation

United States44 participantsStarted 2022-06-23

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Indiv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Characterize Immunoglobulin fragment crystallization modifications

Timeframe: 4 Weeks

Trial details

NCT IDNCT05040204

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-22

Contact for this trial

Emanual Maverakis, MD

916-551-2635 emaverakis@ucdavis.edu

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