Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364254
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-03-08
Brief Title:
Effects of CBD on 2 Mile Run Time Trial Performance
Sponsor:
University of Northern Colorado
Organization:
University of Northern Colorado
Study Overview
Official Title:
The Effects of CBD on 2 Mile Run Time Trial Performance GI Distress and Anxiety in Moderately Active Females
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Individuals who engage in endurance events tend to experience higher levels of stress within the body mind and gut that often lead to impairment of performance Based on previous studies CBD has the potential relieve gut distress and reduce pre-race anxiety thus resulting in an improvement in sport performance Given the current research on the use of CBD in active individuals the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety GI distress and a 2-mile running performance in a moderately active population identifying as female
Detailed Description:
This study will recruit moderately active healthy individuals N30 who identify as female between the ages of 18-40 years who have some running experience and are running at least 2 miles 2 times per week This will be a cross over study so each participant will be their own control receiving either the placebo and CBD on two separate occasions The females recruited will report to the Exercise Physiology lab in Gunter Hall on the University of Northern Colorados campus for testing a total of two times
The first visit will include initial paperwork such as the informed consent physical activity readiness questionnaire PARQ Menstrual Cycle Questionnaire and a screening to determine current activity levels uses CBD THC and any other legal drugsmedications This first interaction allows study staff to ensure that qualify to take part in the study
After informed consent is obtained the participant will be given either the placebo or CBD capsule with a controlled higher fat food 88 Acres protein bar 2 hours before the testing protocol along Once the CBD capsule or placebo is taken participants will complete caffeine consumption exercise and running questionnaires which will be administered on a tablet with study staff after 15 hours or waiting
During the first visit individuals will stay for a standardized period 2 hours before doing a urine analysis to determine hydration status and taking v lactate and heart rate variability Current anxiety symptoms will also be evaluated
Once baseline measurements obtained individuals will then be instructed to run 2 miles a treadmill as fast as possible Lactate will be monitored three times during the test 50 mile mark halfway point 1 mile and just before finishing the time trial run at the 198 mile mark All participants will be taken through a 30-minute cool down period walking 25 mph on the treadmill while having lactate measured every 5 10 15 and 30 minutes post finishing Finish time GI distress questionnaire and overall feelings will be recorded post finish of the 2 mile time trial
Participants will be given a 25-30 day time between visits 1 and 2 to ensure exercise during the same menstrual cycle phase hormone cycle for those that are cycling During the second and final visit participants will undergo the same procedure however will be given the opposite oral administration from the first visit either placebo or CBD
The first visit will include initial paperwork such as the informed consent physical activity readiness questionnaire PARQ Menstrual Cycle Questionnaire and a screening to determine current activity levels uses CBD THC and any other legal drugsmedications This first interaction allows study staff to ensure that qualify to take part in the study
After informed consent is obtained the participant will be given either the placebo or CBD capsule with a controlled higher fat food 88 Acres protein bar 2 hours before the testing protocol along Once the CBD capsule or placebo is taken participants will complete caffeine consumption exercise and running questionnaires which will be administered on a tablet with study staff after 15 hours or waiting
During the first visit individuals will stay for a standardized period 2 hours before doing a urine analysis to determine hydration status and taking v lactate and heart rate variability Current anxiety symptoms will also be evaluated
Once baseline measurements obtained individuals will then be instructed to run 2 miles a treadmill as fast as possible Lactate will be monitored three times during the test 50 mile mark halfway point 1 mile and just before finishing the time trial run at the 198 mile mark All participants will be taken through a 30-minute cool down period walking 25 mph on the treadmill while having lactate measured every 5 10 15 and 30 minutes post finishing Finish time GI distress questionnaire and overall feelings will be recorded post finish of the 2 mile time trial
Participants will be given a 25-30 day time between visits 1 and 2 to ensure exercise during the same menstrual cycle phase hormone cycle for those that are cycling During the second and final visit participants will undergo the same procedure however will be given the opposite oral administration from the first visit either placebo or CBD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None