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临床试验/NCT05508529
NCT05508529已完成不适用

Effect of Natural Immune Modulators on Upper-Respiratory Tract Infections (URTIs) and Psychological Mood State

3 Waves Wellness2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年7月1日最近更新:
适应症

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):

  1. Chaga (mushroom extract)
  2. Arava (algae concentrate)
  3. Thymoquin (black cumin seed oil)
  4. Thymoquin + Astaxanthin (antioxidant carotenoid)
  5. Thymoquin + Omega 3 (fish oil)
  6. 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

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

研究者

发起方
3 Waves Wellness
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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