Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM in Normal Humans
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sulfoquinovose (SQ), ug/mL
研究概览
简要总结
This is a pilot study for identifying plasma and/or urine-derived adherence/surrogate biomarker candidates for verifying Immulina™ ingestion by human volunteers (collected before and after consumption of Immulina™, a natural dietary supplement).
详细描述
This pilot study is interventional, and all participants will receive one 800 mg dose of Immulina™ (four 200 mg capsules), a natural supplement, after a baseline blood and urine collection, then follow with 1 hour, 3 hour and 6 hour post-Immulina™ blood and urine collections. Samples will be sent to UM National Center for Natural Products Research (NCNPR) to analyze and compare timed blood and urine samples using gas chromatography and liquid chromatography to detect volatile and non-volatile compounds, gamma-linolenic acid (GLA), sulfoquinovose (SQ), 5'-methylsulfinyladenosine (MSA), palmitic acid, linoleic acid, palmitoleic acid and oleic acid to screen the chemical fingerprints of the human samples. The mean of the 7 biomarkers for the 4 time points will be measured and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 18-50 years old
- •If female of childbearing potential, using acceptable means of birth control or postmenopausal for at least two years
排除标准
- •pregnant or lactating females
- •significant acute disease
- •recurrent medications for chronic disease
研究组 & 干预措施
Immulina Dietary Supplementation
Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day.
干预措施: Immulina (Drug)
结局指标
主要结局
Sulfoquinovose (SQ), ug/mL
时间窗: Over 7 hour period
Differences in SQ between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
palmitic acid, ug/mL
时间窗: Over 7 hour period
Differences in palmitic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
palmitoleic acid, ug/mL
时间窗: Over 7 hour period
Differences in palmitoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
steric acid, ug/mL
时间窗: Over 7 hour period
Differences in steric acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
gamma-linolenic acid (GLA), ug/mL
时间窗: Over 7 hour period
Differences in GLA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
5'-methylsulfinyladenosine (MSA), ug/mL
时间窗: Over 7 hour period
Differences in MSA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
linoleic acid, ug/mL
时间窗: Over 7 hour period
Differences in linoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
oleic acid, ug/mL
时间窗: Over 7 hour period
Differences in oleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
次要结局
未报告次要终点