Cannabidiol Effects on Cardiovascular System and Exercise Responses

March 26, 2024 updated by: Andrea Corcoran, Castleton University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Castleton, Vermont, United States, 05735
        • Castleton University, Jeffords Science Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will ingest 3ml of non-CBD containing MCT (medium-chain triglycerides) oil.
Drug: Placebo
Placebo oral product formulated in MCT (medium chain triglyceride) oil
Experimental: Cannabidiol 25 mg
Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 25 mg of CBD.
Drug: Cannabidiol
Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil
Other Names:
  • CBD
Experimental: Cannabidiol 50 mg
Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 50 mg of CBD.
Drug: Cannabidiol
Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil
Other Names:
  • CBD
Experimental: Cannabidiol 200 mg
Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 200 mg of CBD.
Drug: Cannabidiol
Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil
Other Names:
  • CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in heart rate variability (HRV) as assessed by time-domain analysis: standard deviation of RR intervals.
Time Frame: 4 weeks
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
Change in heart rate variability (HRV) as assessed by time-domain analysis: root mean square of successive differences.
Time Frame: 4 weeks
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
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: high-frequency (HF).
Time Frame: 4 weeks
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
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: low-frequency (LF).
Time Frame: 4 weeks
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
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: LF/HF ratio.
Time Frame: 4 weeks
A low LF/HF ratio reflects parasympathetic dominance, whereas a high LF/HF ratio reflects sympathetic dominance.
4 weeks
Change in magnitude of autonomic stress test responses as assessed by changes in blood pressure.
Time Frame: Week 5
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
Change in magnitude of autonomic stress test responses as assessed by changes in heart rate.
Time Frame: Week 5
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
Maximal oxygen consumption (VO2max)
Time Frame: 8 days
Maximum oxygen consumption will be calculated during treadmill test (using the Bruce Protocol)
8 days
Heart rate
Time Frame: through study completion, an average of 4 weeks
Change in heart rate will be assessed throughout session
through study completion, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: through study completion, an average of 4 weeks
Change in blood pressure will be assessed throughout session
through study completion, an average of 4 weeks
Borg's Category-Ratio Scale for Rating of Perceived Exertion
Time Frame: 8 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in oxygen saturation
Time Frame: 8 days
percent O2 saturation measured by pulse oximeter throughout session
8 days
Blood lactate
Time Frame: 8 days
Plasma lactate assess by finger stick
8 days
Change in exercise duration
Time Frame: 8 days
Total exercise time on the treadmill while performing the Bruce Protocol.
8 days
Breathing frequency
Time Frame: 8 days
Breathing frequency will be measured throughout session
8 days
Tidal volume
Time Frame: 8 days
Tidal volume will be measured throughout session
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castleton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBRN Project 2022_Corcoran

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe