Impact of Oral Immulina TM on Natural Killer Cell Activities and Other Biomarkers Associated With Increasing Host Immune Resilience to Upper Respiratory Viruses in Normal Human Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Natural Killer cell (NK)-mediated cytotoxicity
研究概览
简要总结
This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resilience to the effects of viral influenza infection in humans.
详细描述
This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on increasing host resilience against the pathogenic effects of influenza virus infection in normal and immune compromised individuals by measuring a biomarker profile designed to reflect immune components associated with antiviral natural killer cell numbers and activity, cytotoxic T cell numbers, vaccine-related flu-specific antibody responses and cytokine profiles associated with host antiviral innate and adaptive immune responses.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-59 (study group 1) or ages 65 and above (study group 2)
- •Any chronic illness must be determined (by PI team) to be stable as evidenced by no changes in medical regimens within 30 days of enrollment.
- •Ability to comprehend the specific activities required to participate in the trial for which the participant is to be enrolled.
排除标准
- •Any acute illness or significant injury within 30 days of enrollment.
- •Specific disease entities, which, in the opinion of the PI, 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-Barr syndrome, Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis.
- •Active autoimmune diseases regardless of clinical stability. A history of autoimmune disease that is not considered active (i.e. no medical therapy for at least 1 year prior to enrollment) will not be excluded.
- •History of unstable chronic illness within 30 days of enrollment.
- •Unable/unwilling to commit to multiple research clinic visits which will be described in detail.
研究组 & 干预措施
Placebo
inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 16 weeks duration.
干预措施: Placebo (Dietary Supplement)
Immulina TM 200 mg/day
Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 2 placebo capsules given by mouth in the evening for 16 weeks duration.
干预措施: Immulina TM (Drug)
Immulina TM 400 mg/day
Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 1-200 mg capsule and 1 placebo capsule given by mouth in the evening for 16 weeks duration.
干预措施: Immulina TM (Drug)
Immulina TM 800 mg/day
Immulina Dietary supplementation (200 mg per capsule); 2-200 mg capsules given by mouth in the morning and 2-200 mg capsules given by mouth in the evening for 16 weeks duration.
干预措施: Immulina TM (Drug)
结局指标
主要结局
Natural Killer cell (NK)-mediated cytotoxicity
时间窗: 20 weeks
NK cell-mediated cytotoxicity is characterized by cytolysis of a CFSE-labeled target cell (K562) by effector cells (NK cells). Labeled K562 are cultured with NK cells for a period of time, then all cells labeled with a live-dead stain, 7-AAD. The cytolytic activity is expressed as the percent dead K562. Differences in cytolytic activity (% dead K562) from baseline to 20 weeks.
次要结局
- Natural Killer (NK) cell count(20 weeks)
- Cytotoxic T lymphocyte (CTL) number(20 weeks)
- Plasma cytokine profile; IL1b, IL6, TNF alpha, IL2, IL7, IL12, IL15 and IL18; pg/mL(20 weeks)
- Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts(20 weeks)
- Influenza A IgG antibody, U/mL(20 weeks)
- serum Interferon gamma, pg/mL(20 weeks)
- serum Interferon alpha, pg/mL(20 weeks)
- Influenza B IgG antibody, U/mL(20 weeks)