Effects of Immulina Dietary Supplementation on Innate and Adaptive Immune Measures in Normal Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Natural Killer (NK) cell count
研究概览
简要总结
This small, randomized, double blind, placebo controlled pilot study is aimed at determining the effects of oral Immulina dietary supplementation on specific immune biomarkers in the blood.
详细描述
This small, randomized, double blind, placebo controlled pilot study is aimed at determining the effects of four weeks of daily Immulina dietary supplementation (800 mg/day) versus four weeks of daily placebo on natural killer (NK) cell numbers and/or natural killer (NK) cell activity in human peripheral blood mononuclear cells collected from human research participants who meet the trial's inclusion/exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal, generally healthy adults between ages 18-64 and who may or may not have a controlled disease(s). Examples of controlled diseases are controlled Type-2 diabetes mellitus, controlled hypertension, controlled allergic rhinitis, etc.
排除标准
- •Individuals with specific disease entities, which, in the opinion of the Principal Investigator, could reasonably be assumed to have dysfunctional immune function as a component of their illness. These include HIV, AIDS, uncontrolled asthma, uncontrolled eczema, uncontrolled allergic rhinitis, uncontrolled urticaria, rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, Type-1 diabetes mellitus, Guillain-Barre syndrome, psoriasis, Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis.
- •Individuals taking specific dietary supplements including probiotic, microalgae or beta glucan containing dietary supplements, fermented food products (such as yogurt, bean curd, etc.). If the potential participants reports usage of any of these products, they will be asked if they would be willing to withhold products for 30 days and then be re-screened for inclusion/exclusion criteria.
- •Individuals who are unwilling to refrain for the duration of the trial from taking the specific dietary supplements and fermented food products including probiotic, microalgae or beta glucan containing dietary supplements, fermented food products (such as yogurt, bean curd, etc.).
- •Pregnant females (because baseline immune responses, are altered by pregnancy)
- •Individuals unable to speak, understand and read English
结局指标
主要结局
Natural Killer (NK) cell count
时间窗: 4 weeks
Differences in NK cell counts from baseline to 4 weeks
次要结局
- Natural Killer (NK) cell cytotoxic activity(4 weeks)
- Immune cell populations(4 weeks)
- Cytokine profiles(4 weeks)
研究者
Gailen D. Marshall Jr., MD PhD
The R. Faser Triplett, Sr., MD Chair of Allergy and Immunology, Professor of Medicine, Pediatrics, Pathology and Population Science
University of Mississippi Medical Center