NCT04466761终止1 期
Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Characterize Immunoglobulin fragment crystallization modifications
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be 18-45 years of age
- •Patients who are in general good health
- •Body Mass Index (BMI) range of 18.5-25
- •All individuals must have the ability to provide inform consent
排除标准
- •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):
- •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
- •On a carbohydrate-restricted or "Paleo" diet
- •Calorie-restricted diet (less than 20%-25% of maintenance calories)
结局指标
主要结局
Characterize Immunoglobulin fragment crystallization modifications
时间窗: 4 Weeks
Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G.
Identify the maximum effective dose
时间窗: 16 Weeks
Identify maximum effective dose of dietary supplement in grams/day.
次要结局
- Quantification of enzymatic modifications measured in grams by spectrometry(6 Months)
- Transcriptome analysis to determine the effect of dietary supplementation on the immune system(6 Months)
- Assess for potential adverse events(2 Months after first dose)
- Flow cytometry to determine the effect of dietary supplementation on the immune system(6 Months)
研究者
研究点 (2)
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