The Effects of CBD on 2 Mile Run Time Trial Performance, GI Distress, and Anxiety in Moderately Active Females
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in Time Trial Times
研究概览
简要总结
Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female.
详细描述
This study will recruit moderately active, healthy individuals (N=30) who identify as female between the ages of 18-40 years who have some running experience and are running at least 2 miles, 2 times per week. This will be a cross over study, so each participant will be their own control, receiving either the placebo and CBD on two separate occasions. The females recruited will report to the Exercise Physiology lab in Gunter Hall on the University of Northern Colorado's campus for testing a total of two times.
The first visit will include initial paperwork such as the informed consent, physical activity readiness questionnaire (PARQ), Menstrual Cycle Questionnaire and a screening to determine current activity levels, uses CBD, THC and any other legal drugs/medications. This first interaction allows study staff to ensure that qualify to take part in the study.
After informed consent is obtained, the participant will be given either the placebo or CBD capsule with a controlled higher fat food (88 Acres protein bar) 2 hours before the testing protocol along. Once the CBD capsule or placebo is taken, participants will complete caffeine consumption, exercise and running questionnaires which will be administered on a tablet with study staff after 1.5 hours or waiting.
During the first visit, individuals will stay for a standardized period (2 hours) before doing a urine analysis to determine hydration status and taking v lactate, and heart rate variability. Current anxiety symptoms will also be evaluated
Once baseline measurements obtained, individuals will then be instructed to run 2 miles a treadmill as fast as possible. Lactate will be monitored three times during the test (.50 mile mark, halfway point (1 mile) and just before finishing the time trial run at the 1.98 mile mark). All participants will be taken through a 30-minute cool down period walking 2.5 mph on the treadmill while having lactate measured every 5, 10, 15, and 30 minutes post finishing. Finish time, GI distress questionnaire, and overall feelings will be recorded post finish of the 2 mile time trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Running at least 2 miles 2 times per week.
排除标准
- •Current diagnosis of a chronic disease or serious mental health disorder.
- •Current or use of cannabis or cannabis products within the past 4 weeks
- •Currently in perimenopause or menopause, transgender female not undergoing hormone treatment (estrogen)
- •Having any underlying health concerns or have any current injuries that can be worsened with exercise
研究组 & 干预措施
Cannabidiol
Cannabidiol capsules 2 hours prior to 2 mile run.
干预措施: Cannabidiol Capsules (Dietary Supplement)
Placebo
Placebo capsules 2 hours prior to 2 mile run.
干预措施: Cannabidiol Capsules (Dietary Supplement)
结局指标
主要结局
Difference in Time Trial Times
时间窗: 10-25 minutes
Time to run 2 miles on an indoor treadmill
Difference in Anxiety Measured with the State Trait Anxiety Inventory
时间窗: 5 minutes
This questionnaire will be administered just before each run to assess the individual's current anxiety symptoms.The State-Trait Anxiety Inventory (STAI) consists of 20 items aimed at evaluating trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Not at all" to "Very much so"). Higher scores suggest elevated anxiety.
Difference in Blood Lactate Concentrations
时间窗: 45 minutes
Blood lactate will be measured just before the time trial, 3 minutes after the start of the run, after 1 mile and 1.98 miles of running and after 5, 10, 15, and 30 minutes of walking recovery. Higher lactate concentrations are associated with more effort during exercise and a slower recovery from exercise.
Different in Heart Rate Variability
时间窗: 5 minutes
The root mean square successive difference method will be used with the 10 second electrocardiogram reading. Higher heart rate variability is associated with better health.
Difference in Gastrointestinal Distress
时间窗: 5 minutes
This questionnaire consists of 12 questions related to distress symptoms. Responses are absent, mild, moderate, severe. The higher the score, the more GI distress is present. This assessment will be completed after the 2 mile run.
次要结局
未报告次要终点
研究者
Laura Stewart
Professor
University of Northern Colorado