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Official title The Effects of Dietary Supplementation on Serum Protein Glycosylation
ClinicalTrials.gov ID: NCT05040204
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25
- 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)...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.