Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity
NCT ID: NCT04114903
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2019-11-08
2024-12-01
Brief Summary
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Detailed Description
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Public perception and some scientific data suggest that cannabis causes acute over-eating, creating concern that public and legal acceptance of cannabis use will worsen the obesity epidemic in the United States, where more than two-thirds of US adults (68.8%) are currently overweight or obese. Paradoxically, cross sectional data demonstrate associations between chronic cannabis use and lower body mass index (BMI), prevalence of obesity, insulin resistance, waist circumference, and actual rates of type 2 diabetes despite data supporting higher caloric intake acutely.
This study examines the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Study A
Adults balanced across the weight spectrum who have tried cannabis at least once with no negative reaction but are not regular users.
Study A: Single use of cannabis flower product
Participants are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
Study B
Sample of current cannabis users and non-users balanced across the weight spectrum who are matched on age, gender, BMI and physical activity.
Study B: Ad libitum cannabis use for four weeks or no cannabis use
Participants choose whether to use a cannabis flower product ad libitum for four weeks or to not use cannabis for four weeks. Participants who choose to use cannabis are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
Interventions
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Study A: Single use of cannabis flower product
Participants are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
Study B: Ad libitum cannabis use for four weeks or no cannabis use
Participants choose whether to use a cannabis flower product ad libitum for four weeks or to not use cannabis for four weeks. Participants who choose to use cannabis are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
Eligibility Criteria
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Inclusion Criteria
* Cannabis users in Study A must have smoked or vaped cannabis at least once since January 1st 2014 with no negative effects but NOT used in the past three months
* Cannabis users in Study B must have been a regular (at least weekly) user for at least a year
* Non-users in Study B cannot have used any cannabis in the previous year
* Weight stable (\<5 pound fluctuation in the past six months)
* Planning to remain in the Boulder-Denver area for the next month
* Fasting blood glucose greater than or equal to 55 mg/dl and less than or equal to 126 mg/dl
* Cannabis users in Study A must endorse knowledge of the procedure(s) for smoking or vaping cannabis
Exclusion Criteria
* Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
* Daily tobacco (cigarette, E-cigs, smokeless) user, given the impact of tobacco smoking on insulin function
* Blood alcohol level greater than 0 at screening
* Current use of medications for glucose lowering, immunosuppression, or anti-inflammation
* Acute illness
* Current use of psychotropic medications
* Current diagnosis of diabetes
* Heavy drinking as defined by an Alcohol Use Disorders Test (AUDIT)
* Females can not be pregnant or trying to become pregnant
* Females can not be nursing mothers
* Have donated blood in the 8 weeks before the study or intend to donate blood in the 8 weeks after the study.
21 Years
40 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
University of Colorado, Boulder
OTHER
Responsible Party
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Angela Bryan
PI
Locations
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Center for Innovation and Creativity
Boulder, Colorado, United States
Countries
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Other Identifiers
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