Are Natural Killer Cells Novel Mediators of the Effects of Cannabidiol on Physical Fitness, Mental Health and Well-Being, Sleep Quantity, Sleep Quantity and Immune Function?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Natural Killer Cell Number and Function
研究概览
简要总结
Chronic inflammation, which is defined as a persistent, low-grade inflammatory response within the body, is associated with many of the negative health conditions which are prevalent in our society today. It is most well-known for its role in the progression of diseases including obesity, metabolic syndrome, cancer, cardiovascular disease, and diabetes. Chronic inflammation is also linked to many of the underlying factors associated with disease development including perturbations in sleep, and mental health status such as depression, anxiety, fatigue, and quality of life. Natural killer cells, commonly referred to as NK cells, are a subset of white blood cells that play an important role in the coordination of inflammation in the body.
Although many interventions aimed at controlling chronic inflammation and enhancing NK cell number and activity have been explored, relatively few have been administered without significant barriers. Cannabidiol (CBD), a non-psychoactive hemp derivative, is a potential, attractive therapeutic target. However, there is very little information in humans that addresses the potential of CBD to improve your health and immune function.
The overall goal of this study is to explore the effects of 8-weeks of CBD supplementation on mental and physical health, sleep measures, and NK cell number and cytotoxic function. Specific Aim 1. Explore the effect of 8-weeks of CBD administration on sleep measures as well as measures of mental and physical health in conjunction with measurements of NK cell number and function.
详细描述
In this double-blind investigation, participants will undergo 8 total visits separated by an 8-week intervention period. One week prior to the intervention period, participants will complete a blood draw, body composition analysis, aerobic and anaerobic fitness analysis, maximal strength testing, and physical activity and sleep quantity and quality analyses. These tests will be completed again following the 8-week intervention period. Following the first 4 visits, participants will be randomly assigned 1 of 2 groups: CBD (50mg/day) or calorie matched placebo. Participants will then complete the 8-week intervention period. Additionally, during week 4 of the 8-week intervention period (intervention midpoint), participants will complete a blood draw, one full week of physical activity and sleep actigraphy, surveys on mental health and wellbeing, and prevalence of sickness and illness
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
A person who does not interact with the study participants will be completing the masking.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be within 18 and 50 years of age
- •Abstained from cannabis (either THC and/or CBD) for the past 6 weeks
- •Have a BMI of 29.9 or below
- •Completes at least 150 minutes of moderate to vigorous physical activity per week.
- •Able and willing to commit to an 8-week intervention schedule
排除标准
- •Significant cardiovascular disorders including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, stroke, or transient ischemic attacks, peripheral vascular disease with intermittent claudication, acute, chronic or recurrent thrombophlebitis.
- •Diagnosed neurological disorders including but not limited to brain tumors, brain injuries, Alzheimer's Disease, Parkinson's Disease, multiple sclerosis, epilepsy, and seizures.
- •Regular use of drugs that significantly alter brain activity such as selective serotonin reuptake inhibitors, benzodiazepines, and others used to treat anxiety, panic, stress, sleep disorders, or increases the risk of sedation and drowsiness.
- •Head trauma with loss of consciousness for more than 30 mins.
结局指标
主要结局
Natural Killer Cell Number and Function
时间窗: 8 Weeks
We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.
Sleep
时间窗: 8 Weeks
We will use a Fitbit Sleep Tracker before and after the intervention.
Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF))
时间窗: 8 Weeks
We will measure circulating BDNF in pre and post intervention samples.
Immune Biomarker (C-Reactive Protein (CRP))
时间窗: 8 Weeks
We will measure serum CRP in pre and post intervention samples.
NK Cell Function
时间窗: 8 Weeks
We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.
Natural Killer Cell Number
时间窗: 8 Weeks
We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.
Physical Activity
时间窗: 8 Weeks
We will use a Fitbit to track physical activity before and after the intervention.
Immune Biomarker (Interleukin 6 (IL-6))
时间窗: 8 Weeks
We will measure serum Il-6 in pre and post intervention samples.
次要结局
- Body Composition(8 Weeks)
- Anaerobic Fitness(8 Weeks)
- Cognitive Function Questionnaire(8 Weeks)
- Anxiety Questionnaire(8 Weeks)
- Depression Questionnaire(8 Weeks)
- Sleep Evaluation Questionnaire(8 Weeks)
- Strength Assessment(8 Weeks)
研究者
Laura Stewart
Professor
University of Northern Colorado