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| ID | Type | Description | Link |
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| 1K24AR077313-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Supplement 1 | Experimental | 6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks |
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| Experimental Supplement 2 | Experimental | 6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks |
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| Experimental Supplement 3 | Experimental | 20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks |
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| Placebo Comparator 1 | Placebo Comparator | 6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks |
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| Placebo Comparator 2 | Placebo Comparator | 6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monosaccharide Powder | Dietary Supplement | Monosaccharide powder dissolved in water. |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterize Immunoglobulin fragment crystallization modifications | Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G. | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess for potential adverse events | Monitor symptoms, severity, and duration of adverse events. | 2 months after first dose |
| Quantification of enzymatic modifications measured in grams by spectrometry |
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Inclusion Criteria:
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
On a carbohydrate-restricted or "Paleo" diet, or calorie-restricted diet (less than 20-25% of maintenance calories)
Adults unable to consent
Prisoners
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanual Maverakis, MD | Contact | 916-551-2635 | emaverakis@ucdavis.edu |
| Name | Affiliation | Role |
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| Emanual Maverakis, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| University of California, Davis Medical Center | Recruiting | Sacramento | California | 95816 | United States |
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| Label | URL |
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| Learn more or sign up for the study here! | View source |
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| Placebo Comparator | Dietary Supplement | Placebo (glucose powder) |
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The investigators will measure enzymatic changes on glycoproteins in the immune system by spectrometry, i.e., these changes will be measured in grams. Spectometry will allow the investigators to quantify these changes in small detail, and therefore give a better idea of how supplementation can change enzymatic process that then affect the structure, and mass, of glycoproteins.
| 6 months |
| Flow cytometry to determine the effect of dietary supplementation on the immune system | Perform flow cytometry on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as translated proteins (measured as height and area of cytokine intensity). | 6 months |
| Transcriptome analysis to determine the effect of dietary supplementation on the immune system | Perform transcriptome analysis on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as RNA (measure on a logarithmic scale per number of reads) to determine the effects of supplementation on both gene transcription and translation. | 6 months |