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The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS). Healthy adults ages 18-65 years who are exercise-trained (self-report exercising at least 3 times per week for at least 30 minutes per session for the past year) will be recruited from existing panels of participants from past studies, local advertisements, and social media targeted advertisements. Those who meet the inclusion/exclusion criteria will be enrolled into the study, scheduled for the Exercise Visit (Study Visit 1; Day 0) within 2 weeks of screening, and randomized to active vs. placebo IP condition in a 1:1 ratio. One repetition maximum (1RM) method, the maximum amount of weight one can lift in a single repetition for a given exercise, will be used in order to induce DOMS. Following the completion of the Exercise Visit, participants will be scheduled for 3 follow-up visits that will occur 1, 2, and 3 days post-Exercise Visit. Participants will consume 7 scheduled doses of the study IP to which they have been randomly assigned (i.e., active or placebo) with instruction to consume the study IP prior to the exercise at Study Visit 1, at 8PM (±1 hour) that night, and then at 8AM and 8PM (±1 hour) every day until their final study visit. The last dose will occur at 8AM (±1 hour) on Day 4, i.e., immediately prior to Study Visit 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | CHI-202. Participants will drink one 7.0g CHI-202 powder sachet mixed into 16oz of water twice daily. |
|
| Placebo | Placebo Comparator | CHI-101. Participants will drink one 7.0g CHI-101 powder sachet mixed into 16oz of water twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHI-202 | Dietary Supplement | Blend of cannabinoids & other ingredients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in blood pressure (mmHg) [Safety and Tolerability] | Blood pressure is measure by the combination of systolic and diastolic measurements | Day 2 |
| Changes from baseline in blood pressure (mmHg) [Safety and Tolerability] | Blood pressure is measure by the combination of systolic and diastolic measurements | Day 3 |
| Changes from baseline in blood pressure (mmHg) [Safety and Tolerability] | Blood pressure is measure by the combination of systolic and diastolic measurements | Day 4 |
| Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability] | Respiratory rate will be measured as breaths per minute | Day 2 |
| Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability] | Respiratory rate will be measured as breaths per minute | Day 3 |
| Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability] | Respiratory rate will be measured as breaths per minute | Day 4 |
| Changes from baseline in heart rate (beats per minute) [Safety and Tolerability] | Heart rate will be measured as heart beats per minute | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Average soreness or discomfort intensity using the 11-point (0-10) NRS | Self-reported average soreness or discomfort intensity using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity | Day 1 - post DOMS intervention |
| Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Peters, PhD | Canopy Growth Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Society for Sports Nutrition | Boca Raton | Florida | 33432 | United States |
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Double-blind, randomized
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| CHI-101 |
| Dietary Supplement |
Placebo |
|
| Changes from baseline in heart rate (beats per minute) [Safety and Tolerability] | Heart rate will be measured as heart beats per minute | Day 3 |
| Changes from baseline in heart rate (beats per minute) [Safety and Tolerability] | Heart rate will be measured as heart beats per minute | Day 4 |
| Total number of Adverse Events [Safety and Tolerability] | Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events | Through study completion (Day 4) |
| Total number of participants with Adverse Events [Safety and Tolerability] | Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events | Through study completion (Day 4) |
| Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability] | Safety and tolerability will be assessed through Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) | Through study completion (Day 4) |
Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity |
| Day 2 |
| Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity | Day 3 |
| Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity | Day 4 |
| Worst soreness or discomfort intensity using the 11-point (0-10) NRS | Self-reported worst soreness or discomfort intensity using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity | Day 1 - post DOMS intervention |
| Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity | Day 2 |
| Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity | Day 3 |
| Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity | Day 4 |
| Average stiffness intensity using the 11-point (0-10) NRS | Self-reported average stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 1 - post DOMS intervention |
| Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 2 |
| Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 3 |
| Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 4 |
| Worst stiffness intensity using the 11-point (0-10) NRS | Self-reported worst stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 1 - post DOMS intervention |
| Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 2 |
| Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 3 |
| Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS | Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity | Day 4 |
| Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS | Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference | Day 2 |
| Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS | Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference | Day 3 |
| Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS | Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference | Day 4 |
| Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS | Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference | Day 2 |
| Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS | Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference | Day 3 |
| Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS | Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference | Day 4 |
| Self-reported sleep quality using the 11-point (0-10) NRS | Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality | Day 2 |
| Self-reported sleep quality using the 11-point (0-10) NRS | Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality | Day 3 |
| Self-reported sleep quality using the 11-point (0-10) NRS | Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality | Day 4 |
| Self-reported sleep duration via a sleep diary | Self-reported sleep duration measured in minutes via a sleep diary | Day 2 |
| Self-reported latency to sleep onset via a sleep diary | Self-reported latency to sleep onset measured in minutes via a sleep diary | Day 2 |
| Self-reported sleep continuity via a sleep diary | Self-reported sleep continuity measured in minutes via a sleep diary | Day 2 |
| Self-reported alertness upon waking via a sleep diary | Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy | Day 2 |
| Self-reported sleep duration via a sleep diary | Self-reported sleep duration measured in minutes via a sleep diary | Day 3 |
| Self-reported latency to sleep onset via a sleep diary | Self-reported latency to sleep onset measured in minutes via a sleep diary | Day 3 |
| Self-reported sleep continuity via a sleep diary | Self-reported sleep continuity measured in minutes via a sleep diary | Day 3 |
| Self-reported alertness upon waking via a sleep diary | Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy | Day 3 |
| Self-reported sleep duration via a sleep diary | Self-reported sleep duration measured in minutes via a sleep diary | Day 4 |
| Self-reported latency to sleep onset via a sleep diary | Self-reported latency to sleep onset measured in minutes via a sleep diary | Day 4 |
| Self-reported sleep continuity via a sleep diary | Self-reported sleep continuity measured in minutes via a sleep diary | Day 4 |
| Self-reported alertness upon waking via a sleep diary | Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy | Day 4 |
| Pressure threshold | Pressure threshold measured with a 25-lb algometer | Day 1 - post DOMS intervention |
| Pressure threshold | Pressure threshold measured with a 25-lb algometer | Day 2 |
| Pressure threshold | Pressure threshold measured with a 25-lb algometer | Day 3 |
| Pressure threshold | Pressure threshold measured with a 25-lb algometer | Day 4 |
| Relaxed elbow angle | Relaxed elbow angle measured with a goniometer in degrees | Day 1 - post DOMS intervention |
| Active range of motion | Active range of motion measured with a goniometer in degrees | Day 1 - post DOMS intervention |
| Passive range of motion | Passive range of motion measured with a goniometer in degrees | Day 1 - post DOMS intervention |
| Relaxed elbow angle | Relaxed elbow angle measured with a goniometer in degrees | Day 2 |
| Active range of motion | Active range of motion measured with a goniometer in degrees | Day 2 |
| Passive range of motion | Passive range of motion measured with a goniometer in degrees | Day 2 |
| Relaxed elbow angle | Relaxed elbow angle measured with a goniometer in degrees | Day 3 |
| Active range of motion | Active range of motion measured with a goniometer in degrees | Day 3 |
| Passive range of motion | Passive range of motion measured with a goniometer in degrees | Day 3 |
| Relaxed elbow angle | Relaxed elbow angle measured with a goniometer in degrees | Day 4 |
| Active range of motion | Active range of motion measured with a goniometer in degrees | Day 4 |
| Passive range of motion | Passive range of motion measured with a goniometer in degrees | Day 4 |
| Muscle circumference | Muscle circumference | Day 1 - post DOMS intervention |
| Muscle circumference | Muscle circumference | Day 2 |
| Muscle circumference | Muscle circumference | Day 3 |
| Muscle circumference | Muscle circumference | Day 4 |
| Mood using the Profile of Mood States | Mood using the Profile of Mood States | Day 1 - post DOMS intervention |
| Mood using the Profile of Mood States | Mood using the Profile of Mood States | Day 2 |
| Mood using the Profile of Mood States | Mood using the Profile of Mood States | Day 3 |
| Mood using the Profile of Mood States | Mood using the Profile of Mood States | Day 4 |