NCT05040204招募中1 期
The Effects of Dietary Supplementation on Serum Protein Glycosylation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Characterize Immunoglobulin fragment crystallization modifications
研究概览
简要总结
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.
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
- •Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25
排除标准
- •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
研究组 & 干预措施
Experimental Supplement 1
Experimental
6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks
干预措施: Monosaccharide Powder (Dietary Supplement)
Experimental Supplement 2
Experimental
6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks
干预措施: Monosaccharide Powder (Dietary Supplement)
Experimental Supplement 3
Experimental
20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks
干预措施: Monosaccharide Powder (Dietary Supplement)
Placebo Comparator 1
Placebo Comparator
6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks
干预措施: Placebo Comparator (Dietary Supplement)
Placebo Comparator 2
Placebo Comparator
6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks
干预措施: Placebo Comparator (Dietary Supplement)
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.
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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