Cannabidiol Effects on Cardiovascular System and Exercise Responses

Healthy Clinical Trial

Official title:

Cannabidiol Effects on Cardiovascular System and Exercise Responses

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05232123
• Other study ID #: VBRN Project 2022_Corcoran
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: July 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Castleton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo
Placebo oral product formulated in MCT (medium chain triglyceride) oil
• Cannabidiol
Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil

Locations

Country	Name	City	State
United States	Castleton University, Jeffords Science Building	Castleton	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Castleton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in oxygen saturation	percent O2 saturation measured by pulse oximeter throughout session	8 days
Other	Blood lactate	Plasma lactate assess by finger stick	8 days
Other	Change in exercise duration	Total exercise time on the treadmill while performing the Bruce Protocol.	8 days
Other	Breathing frequency	Breathing frequency will be measured throughout session	8 days
Other	Tidal volume	Tidal volume will be measured throughout session	8 days
Primary	Change in heart rate variability (HRV) as assessed by time-domain analysis: standard deviation of RR intervals.	Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: standard deviation of RR intervals (SDNN). Higher values indicate greater HRV.	4 weeks
Primary	Change in heart rate variability (HRV) as assessed by time-domain analysis: root mean square of successive differences.	Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: root mean square of successive differences (RMSSD). Higher values indicate greater HRV.	4 weeks
Primary	Change in heart rate variability (HRV) as assessed by frequency-domain analysis: high-frequency (HF).	Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). A high HF reflects parasympathetic dominance.	4 weeks
Primary	Change in heart rate variability (HRV) as assessed by frequency-domain analysis: low-frequency (LF).	Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). LF reflects both sympathetic and parasympathetic activity.	4 weeks
Primary	Change in heart rate variability (HRV) as assessed by frequency-domain analysis: LF/HF ratio.	A low LF/HF ratio reflects parasympathetic dominance, whereas a high LF/HF ratio reflects sympathetic dominance.	4 weeks
Primary	Change in magnitude of autonomic stress test responses as assessed by changes in blood pressure.	Responses to autonomic stress test include a change in blood pressure if sympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.	Week 5
Primary	Change in magnitude of autonomic stress test responses as assessed by changes in heart rate.	Responses to autonomic stress test include a change in heart rate if parasympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.	Week 5
Primary	Maximal oxygen consumption (VO2max)	Maximum oxygen consumption will be calculated during treadmill test (using the Bruce Protocol)	8 days
Primary	Heart rate	Change in heart rate will be assessed throughout session	through study completion, an average of 4 weeks
Secondary	Blood pressure	Change in blood pressure will be assessed throughout session	through study completion, an average of 4 weeks
Secondary	Borg's Category-Ratio Scale for Rating of Perceived Exertion	The Borg Scale is a self-reporting instrument assessing intensity of perceived exertion on a 0 to 10 scale, 0 being rest and 10 maximal effort.	8 days