Cannabidiol and Focus Study (CBD-Focus)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Natural Killer (NK) Cell Function
研究概览
简要总结
Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. Natural killers cells (NKC) play a vital role in maintain your body's defenses and are an essential component of your immune system. In humans, NKC contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.
详细描述
BACKGROUND: Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. In humans, natural killer cells (NKC) contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.
METHODS: In this double-blind, placebo-controlled, 4 arm clinical trial, male and female participants will undergo 2 pre intervention study visits and 3 post intervention study visits separated by an 8-week intervention period. Participants must be aged 18-50 years old, currently completing at least 150 minutes of moderate to vigorous physical activity per week, have a body mass index under 29.9, with no significant physical or mental health (without the presence of chronic depression or anxiety) conditions. Subjects may not have an allergy to soy. All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks. Supplementation groups will be randomly assigned into groups consuming one of 4 beverages: 1) a beverage with 40 mg of CBD (CBD40, n=50), 2) a beverage with 20 mg of CBD (CBD20, n=50), 3) a beverage with 0 mg of CBD (CBD0, n=50) or 4) calorie-matched placebo (PLAC, n=50).
INTERVENTION DESCRIPTION: Participants will be instructed to consume one beverage per day following their last meal, 1-1.5h before bed. Four weeks of beverages will be provided at a time. These beverage deposits will include an in person check in at the midpoint of the study. Participants and researchers will be blinded to the intervention groups. All participants will be given a 4-week supply of beverages. Investigators will meet with participants weekly via zoom/phone call and to report any adverse side effects or changes in physical activity routine. All products will be provided by Ocean Spray. All products are hemp derived, within legal limits and have had their purity verified. Following the completion of data collection for all study participants, researchers will be unblinded to supplementation groups.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Currently completing at least 150 minutes of moderate to vigorous physical activity per week
- •Have a body mass index under 29.9
- •No significant physical or mental health (without the presence of chronic depression or anxiety) conditions
- •No presence or past diagnosis of eating disorders
排除标准
- •Subjects may not have an allergy to soy.
- •All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks.
- •Participants receive a $200 Visa Gift Card after the last study visit is completed.
结局指标
主要结局
Change in Natural Killer (NK) Cell Function
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
NK Cell Cellular Function Assay using Flow Cytometry
Change in Fatigue Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Piper Fatigue Questionnaire. A higher score suggests higher levels of fatigue.
Change in Sleep Assessment
时间窗: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
Sleep Assessment (7 day). We will use Fitbits to track sleep.
Change in Physical Activity (steps per day)
时间窗: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
Physical Activity Assessment (7 day). We will use Fitbits to track physical activity.
Change in General Anxiety Disorder Questionnaire Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
General Anxiety Disorder Questionnaire 7. A higher score suggests higher levels of anxiety.
Change in Psychological Wellbeing Scale Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Psychological Wellbeing Questionnaire. A higher score suggests better wellbeing.
Change in Cognitive Function and Abilities Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Abilities - Short Form 8a. A higher score suggests higher cognitive ability.
Change in Natural Killer (NK) Cell Number
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
NK Cell Counts obtained on a flow cytometer.
Change in a Biomarker of Inflammation
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum C-Reactive Protein
Change in Perceived Stress Scale Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Perceived Stress Questionnaire. A higher score suggests higher perceived stress.
Change in Maximal Anaerobic Power
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Wingate Power Test
Change in a Biomarker of Neural Health
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Circulating Brain Derived Neurotropic Factor
Change in Quality of Life Questionnaire Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Ferrans and Powers Quality of Life Index Questionnaire. A higher scores suggests higher quality of life.
Change in Sleep Questionnaire Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Leeds Sleep Questionnaire. Lower scores generally suggest better sleep.
Change in Athlete Sickness and Illness Assessment Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
The Wisconsin Upper Respiratory Symptom Survey. A higher scores suggests more respiratory symptoms.
Change in Sustained Attention to Response Task (SART) Activity
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Sustained Attention to Response Task (SART) Activity
Change in a Stress Biomarker
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum Cortisol
Change in Liver Health Biomarker I
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum Aspartate aminotransferase (AST)
Change in Liver Health Biomarker II
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum Alanine aminotransferase (ALT)
Change In Cognitive Function Score
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
PROMIS Cognitive Function - Short Form 8a. A higher score suggests higher cognitive ability.
Change in Kidney Health Biomarker
时间窗: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Serum creatinine
次要结局
未报告次要终点
研究者
Laura Stewart
Professor
University of Northern Colorado