Effects of Cannabis Oil on respiratory and cardiovascular function in healthy individuals: a randomized clinical trial study

INTERVENTION: This is a three‐arm crossover clinical trial, therefore the sample will be allocated to a single group of 30 individuals who will participate in three phases with three interventions: Full Spectrum oil (12.25 mg in drops), THC Oil (12 .25 mg in drops) and placebo intervention (same amount in drops of MCT oil ‐ Mediun Chain Triglycerides). Randomization will be carried out by an external researcher, who will generate a sequence in three blocks, with the order of interventions being random, informed on the day of each intervention to researchers and evaluators, the bottles will all be the same, with an identification label (A, B and C). The intervention will involve one of the researchers administering the oil orally using a dropper, followed by 60 minutes of rest and monitoring of vital signs and general condition, with assessment steps being carried out after this time. Interventions and assessments will be carried out on three non‐consecutive days. The subjects will perform several pulmonary function tests with spirometry, P01, MVV, Pima Xand Pema Xfor data characterization and normalization, in addition to the evaluation sequence consisting of: 6 minutes of evaluation of variations in chest wall volumes and respiratory mechanics through Plethysmography Optoelectronics, Electromyography of the inspiratory muscles, oxygenation and blood flow in the peripheral muscles through NIRS (Near Infrared Spectroscopy), and assessment of hemodynamics by electrical impedance through Physioflow where 2 minutes of spontaneous breathing (QB), 2 minutes of a maneuver will be recorded of PowerBreathe with a load 30% of the subject's Pima X(VALVE) and another 2 minutes in spontaneous breathing (REC), this will be repeated after 60 minutes (in) of the intervention and again after 150 CONDITION: Healthy Volunteers M01.955 PRIMARY OUTCOME: Cardiovascular hemodynamic assessment, measuring heart rate, cardiac output index, left ventricular systolic work index and systemic vascular resistance index, using PhysioFlow®, which is a non‐invasive cardiac output monitor that provides hemodynamic parameters in pre, in and post intervention measurements It is expected to find the respiratory drive verified by measuring Airway Occlusion Pressure (P0.1). P0.1 is a measurement of the pressure generated spontaneously in the initial inspiratory effort, at the end of a forced expiration using a vacuum manometer device. The measurement is given in cm H2O, and will also be evaluated in % of predicted to check the respiratory drive in pre, in and post intervention measurements. To evaluate the variation in the electrical activity of the respiratory muscles at rest and during the use of moderate inspiratory load, using the Electromyography evaluation method of the sternocleidomastoid, scalene, parasternal and rectus abdominis muscles, using sensors attached to the bellies of the muscles. The results are given on frequency and time scales that will be analyzed and transformed into percentages of the Root Mean Square (RMS), median frequencies, high pass and low pass powers. We will observe the behavior of respiratory muscle electrical activity under the effect of cannabis oils and placebo in pre, in and post intervention assessments SECONDARY OUTCOME: Assess fatigue and dyspnea perceived and reported by the participant will be evaluated using the Borg and Dyspnea Scale, a numerical scale from 0 to 10, where 0 indicates no fatigue or shortness of breath and 10 indicates the greatest fatigue or shortness of breath reported, measures in the rest, valve and recovery phases, in the moments before, during and after intervention Evaluate respiratory mechanics through Optoelectronic Plethysmography (BTS Bioengineering) where tidal volume values ??of the chest wall and its compartments (liters) can be observed, as well as measurements of time (seconds), respiratory frequency (rpm) and percentage of participation of each compartment (%), in pre, in and post intervention measurements It is expected to identify the presence and severity of anxiety symptoms in the participant using the Hamilton Anxiety Scale composed of 14 items, scored from 0 (not present) to 4 (severe), with a total score of 0 to 56, where the score <17 indicates a mild degree of anxiety, between 18 and 24 points indicates moderate severity and between 25 and 30 points indicates moderate to severe anxiety, before, during and after using the interventions To evaluate muscle oxygenation during inspiratory effort with load under the effect of the proposed interventions using the near‐infrared spectroscopy (NIRS) technique coupled to the vastus medialis muscle in pre‐, in‐ and post‐intervention measurements, which presents measurements of absolute concentrations of oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), total hemoglobin (tHb) and tissue saturation inde Xin muscle tissue (TSI) in measurements before, during and after the intervention INCLUSION CRITERIA: Both sexes; young people; between 18 and 50 years old; who declare themselves healthy; with body mass inde X(BMI) within normal limits; that do not present changes in respiratory function; do not present uncontrolled/treated psychological disorders; do not use regular medications; have not had exposure to Cannabis in the last 6 months