Effect of Natural Immune Modulators on Upper-Respiratory Tract Infections (URTIs) and Psychological Mood State
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Microbiome Balance
研究概览
简要总结
The objective of this proposal is to recruit 20 healthy subjects per ingredient arm (5 arms x 20 subjects; N= 120 total) to participate in a research study investigating the effects of dietary supplementation for one-month with different dietary supplement formulations (versus placebo; N=20) that may have benefits for supporting respiratory health, psychological stress, and quality of life.
Supplements to be studied (all are commercially available):
- Chaga (mushroom extract)
- Arava (algae concentrate)
- Thymoquin (black cumin seed oil)
- Thymoquin + Astaxanthin (antioxidant carotenoid)
- Thymoquin + Omega 3 (fish oil)
- Placebo (corn starch)
In order to "stress" volunteers, participants will train for and complete a strenuous off-road trail marathon to induce both physical and mental stress.
详细描述
The main hypothesis is that the group(s) supplementing with natural stress modulators will demonstrate superior subjective assessments of both physical health (e.g. respiratory function, mobility, flexibility) and mental stress (e.g. mood, energy, focus).
Stress-related factors following intense endurance activity can lead to a range of adverse physical manifestations including muscle soreness, physical fatigue, and general malaise. Furthermore, stressful events frequently lead to negative emotions including temporary reductions in perceived mood and energy with heightened irritability and tension.
Each of the ingredients under consideration for this study, Chaga, Algae extract, Black Cumin Seed Oil, Astaxanthin, and Omega-3s, have a number of laboratory and animal studies demonstrating anti-stress benefits including improvements in physical mobility (e.g. flexibility), mental energy, and overall well-being.
Each of these ingredients may be considered as natural "stress-modulators" that can help to balance overall well-being and quality of life. Such natural substances represent an emerging approach to buffer the detreimnetal effects of physical and mental stressors.
Mushrooms, particularly Chaga, have a long history of use in traditional medicine for supporting general well-being. An abundance of in-vitro evidence suggests that a wide range of mushroom bioactives may modify stress responses, with promising preliminary research in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
randomized, placebo-controlled, with coded bottles for each group
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females age 18 to 60 years
- •Ability to complete strenuous off-road trail run, and planning to do so regardless of the study
- •Willingness to consume the dietary supplements under investigation
- •Willingness to undertake all protocol measurements and training regimens
- •Ability to understand and sign the informed consent form (ICF)
排除标准
- •Any supplements or medications that are stress/immune-suppressive or stress/immune-stimulant (e.g. herbal stimulants).
- •Pregnant or lactating
结局指标
主要结局
Microbiome Balance
时间窗: 1 month
Streptococcus thermophilus (relative abundance)
Psychological Mood State (e.g. stress)
时间窗: 1 month
"Global Well-Being" index as collected by the validated Profile of Mood States Survey (POMS)
Health Log
时间窗: 1 month
total number of subjective upper respiratory tract complaints per subject (e.g. sore throat, cough, etc)
Stress Hormones
时间窗: 1 month
Salivary Cortisol (ng/ml)
次要结局
未报告次要终点
