Effects of dietary supplements on immune system proteins
The Effects of Dietary Supplementation on Serum Protein Glycosylation
This study is testing whether a dietary supplement can improve the immune system in healthy adults by looking at changes in certain immune proteins.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05040204 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves two randomized double-blind placebo-controlled studies aimed at evaluating how dietary glycan monomer supplementation influences the immune system, particularly focusing on antibody glycosylation in healthy adults. Participants will receive either a monosaccharide powder or a placebo, and their serum will be analyzed for immune profiling and glycoproteomics at various time points. The study targets adults aged 18 to 45 who are in good health and have a BMI within the normal range.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 45 with a BMI between 18.5 and 25.
Not a fit: Patients outside the age range of 18 to 45, those with autoimmune conditions, or individuals with certain health issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how dietary supplements can modulate immune function and improve health outcomes.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promise in understanding the effects of dietary supplements on immune function.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California
- University of California, Davis Medical Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Emanual Maverakis, MD — University of California, Davis
- Study coordinator: Emanual Maverakis, MD
- Email: emaverakis@ucdavis.edu
- Phone: 916-551-2635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.