Cannabidiol Effects on Cardiovascular System and Exercise Responses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will receive a different dose in consecutive weeks (one of which is a placebo), thus serving as their own control.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Participants will ingest 3ml of non-CBD containing MCT (medium-chain triglycerides) oil.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral product formulated in MCT (medium chain triglyceride) oil

Cannabidiol 25 mg

Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 25 mg of CBD.

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil

Cannabidiol 50 mg

Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 50 mg of CBD.

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil

Cannabidiol 200 mg

Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 200 mg of CBD.

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil

Interventions

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Placebo

Placebo oral product formulated in MCT (medium chain triglyceride) oil

Intervention Type DRUG

Cannabidiol

Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil

Intervention Type DRUG

Other Intervention Names

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CBD

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes