Clinical trial NCT05232123: Cannabidiol Effects on Cardiovascular System and Exercise Responses
Official title: Cannabidiol Effects on Cardiovascular System and Exercise Responses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Castleton University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive a different dose in consecutive weeks (one of which is a placebo), thus serving as their own control.
Primary purpose: BASIC_SCIENCE

Brief summary: To identify the autonomic effects of recreationally-relevant doses of cannabidiol (CBD) in an older population, and to evaluate the effect of CBD on exercise performance and recovery.

Detailed description: Heart rate variability (HRV) analysis is a common method used to evaluate the function of the autonomic nervous system. While heart rate is the number of heart beats per minute, HRV is the fluctuation of the time intervals between those beats (interbeat intervals). If the interbeat intervals are too similar, this is an indication of an unhealthy heart. A major influence on heart rate (and thus interbeat interval), is the autonomic nervous system which is divided into two branches: sympathetic and parasympathetic. HRV represents the balance between both systems, with higher HRV being associated with greater parasympathetic activity, and lower HRV with greater sympathetic activity. While there is no optimal level of HRV, a higher HRV is associated with reduced stress and good health, and a lower HRV is associated with chronic diseases and cardiovascular risk. The current study will evaluate the effect of recreationally-relevant doses of CBD (25-200mg) on resting HRV in older adults (aims 1\&2). Investigators will also look at the effects of CBD on cardiovascular fitness by having participants complete a maximum graded exercise test under the influence of a placebo and again after ingesting a single dose of CBD (aims 3\&4).

Eligibility criteria: Inclusion Criteria:

* male or female
* 18+ years (aims 3\&4)
* 50+ years (aims 1\&2)
* participants must agree to fast for 4 hours and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session
* participants must agree to avoid exercise for 6 hours prior to each experimental session
* completion of Health History Screening Questionnaire with report indicating overall good health
* ability to comprehend and satisfactorily comply with protocol requirements
* written informed consent given prior to study participation
* low-risk for VO2max testing (aims 3\&4)

Exclusion Criteria:

* women who are pregnant or lactating
* participants who have a history of adverse reactions to cannabidiol
* current medications that might influence the cardiovascular and/or autonomic systems
* any cardiac, pulmonary, renal, or metabolic disease
* walking difficulty (aims 3\&4)
* waiting for a stress test for a medical reason (aims 3\&4)
* medical contraindication to performing a treadmill stress test (aims 3\&4)

Primary outcomes:
measure: Change in heart rate variability (HRV) as assessed by time-domain analysis: standard deviation of RR intervals.
timeFrame: 4 weeks
measure: Change in heart rate variability (HRV) as assessed by time-domain analysis: root mean square of successive differences.
timeFrame: 4 weeks
measure: Change in heart rate variability (HRV) as assessed by frequency-domain analysis: high-frequency (HF).
timeFrame: 4 weeks
measure: Change in heart rate variability (HRV) as assessed by frequency-domain analysis: low-frequency (LF).
timeFrame: 4 weeks
measure: Change in heart rate variability (HRV) as assessed by frequency-domain analysis: LF/HF ratio.
timeFrame: 4 weeks
measure: Change in magnitude of autonomic stress test responses as assessed by changes in blood pressure.
timeFrame: Week 5
measure: Change in magnitude of autonomic stress test responses as assessed by changes in heart rate.
timeFrame: Week 5
measure: Maximal oxygen consumption (VO2max)
timeFrame: 8 days
measure: Heart rate
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: through study completion, an average of 4 weeks
measure: Borg's Category-Ratio Scale for Rating of Perceived Exertion
timeFrame: 8 days
Other outcomes:
measure: Change in oxygen saturation
timeFrame: 8 days
measure: Blood lactate
timeFrame: 8 days
measure: Change in exercise duration
timeFrame: 8 days
measure: Breathing frequency
timeFrame: 8 days
measure: Tidal volume
timeFrame: 8 days
Locations:
city: Castleton
country: United States
facility: Castleton University, Jeffords Science Building
state: Vermont
Study officials:
References: