Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Interferon gamma (IFNg)
研究概览
简要总结
This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 and older;
- •Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).
排除标准
- •Inability to comprehend and speak English;
- •Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data;
- •Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.
研究组 & 干预措施
Placebo
10 participants will be randomized to take 1 capsule of placebo daily.
干预措施: Immulina (Dietary Supplement)
Immulina 200 mg/day
10 participants will be randomized to take 200 mg/day of Immulina.
干预措施: Immulina (Dietary Supplement)
Immulina 400 mg/day
10 participants will be randomized to take 400 mg/day of Immulina.
干预措施: Immulina (Dietary Supplement)
Immulina 800 mg/day
10 participants will be randomized to take 800 mg/day of Immulina.
干预措施: Immulina (Dietary Supplement)
结局指标
主要结局
Interferon gamma (IFNg)
时间窗: 8 weeks
Increase in IFNg from baseline to 8 weeks
次要结局
- Psychological Measures(8 weeks)
- Optimal supplement regime(8 weeks)
- Demographic differences(8 weeks)
- Immune biomarkers(8 weeks)
研究者
Gailen D. Marshall
Professor of Medicine and Pediatrics, Vice Chair for Research, Department of Medicine, Director, Division of Clinical Immunology and Allergy, Chief, Laboratory of Behavioral Immunology Research
University of Mississippi Medical Center