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Cannabidiol Effects on Cardiovascular System and Exercise Responses

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ClinicalTrials.gov Identifier: NCT05232123
Recruitment Status : Not yet recruiting
First Posted : February 9, 2022
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Andrea Corcoran, Castleton University

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Drug: Cannabidiol Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cannabidiol Effects on Cardiovascular System and Exercise Responses
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

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 Name: 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 Name: 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 Name: CBD




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Maximal oxygen consumption (VO2max) [ Time Frame: 8 days ]
    Maximum oxygen consumption will be calculated during treadmill test (using the Bruce Protocol)

  9. Heart rate [ Time Frame: through study completion, an average of 4 weeks ]
    Change in heart rate will be assessed throughout session


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: through study completion, an average of 4 weeks ]
    Change in blood pressure will be assessed throughout session

  2. 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.


Other Outcome Measures:
  1. Change in oxygen saturation [ Time Frame: 8 days ]
    percent O2 saturation measured by pulse oximeter throughout session

  2. Blood lactate [ Time Frame: 8 days ]
    Plasma lactate assess by finger stick

  3. Change in exercise duration [ Time Frame: 8 days ]
    Total exercise time on the treadmill while performing the Bruce Protocol.

  4. Breathing frequency [ Time Frame: 8 days ]
    Breathing frequency will be measured throughout session

  5. Tidal volume [ Time Frame: 8 days ]
    Tidal volume will be measured throughout session



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05232123


Locations
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United States, Vermont
Castleton University, Jeffords Science Building
Castleton, Vermont, United States, 05735
Sponsors and Collaborators
Castleton University
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Responsible Party: Andrea Corcoran, Assistant Professor of Exercise Science, Castleton University
ClinicalTrials.gov Identifier: NCT05232123    
Other Study ID Numbers: VBRN Project 2022_Corcoran
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cannabidiol
Anticonvulsants