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The IRB closed the protocol. PI failed to submit study for continuing review.
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The investigators will conduct a parallel-group, placebo-controlled, randomized, double-blind ascending dose Phase I study of dietary supplementation in healthy individuals to evaluate safety and to determine the pharmacologically effective dose (ED).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort 1-4 | Experimental | 60% of subjects per cohort will consume 30-90 grams of dietary supplement daily for 4 weeks, with each successive cohort dosage increasing according to a Fibonacci dose escalation. |
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| Placebo: Cohort 1-4 | Placebo Comparator | 40% of subjects per cohort will consume 30-90 grams of daily placebo for 4 weeks with each successive cohort dosage increasing in parallel to the experimental arm. |
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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 |
| Identify the maximum effective dose | Identify maximum effective dose of dietary supplement in grams/day. | 16 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:
Women who are pregnant, actively nursing, or pregnant 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
Past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
Individuals with first degree relative with history of an autoimmune condition
Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any kind
Individuals with diagnosis of galactosemia or congenital disorders of glycosylation
Individuals with phenylketonuria
Individuals currently taking prescription medications, or have taken prescription medications within the last 3 months
Individuals currently taking over the counter medications
Individuals currently taking or 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 prior history of severe food or drug allergic reactions
Individuals with a diagnosis of type I or II diabetes mellitus
Individuals with allergic reaction or adverse reaction to shellfish, N-acetyl glucosamine, galactose, or Spirulina/chlorella/algae supplements
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 to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet in our study population):
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| Name | Affiliation | Role |
|---|---|---|
| Emanual Maverakis, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95630 | United States |
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| Placebo Comparator | Other | Placebo (cellulose 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 |