Trial Outcomes & Findings for Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity (NCT NCT04114903)

Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity

Change in Circulating Levels of Cytokines (TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4). Results are reported as a composite score of TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4

Calculation of Insulin Sensitivity using changes in fasting plasma glucose (FPG) and fasting plasma insulin (FPI). Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes after ingestion of 75 grams oral glucose during oral glucose tolerance test (OGTT). Values across the timepoints were combined to create a Matsuda Index score as follows: 10000/sqrt ((FPG X FPI) X (Mean OGTT glucose concentration X Mean OGTT insulin concentration)). Higher scores mean higher sensitive to insulin and that your body more efficiently clears glucose from your bloodstream, thus higher scores are better.

Change in glucose over time after ingestion of 75 grams oral glucose measured during during oral glucose tolerance test (OGTT). Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.

Change in insulin over time after ingestion of 75 grams oral glucose measured during OGTT. Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.

Interviewer administered assessment of number of minutes of moderate to vigorous physical activity over the previous seven days. Scores are reported as total minutes in the last week summed across moderate, hard, and very hard activity levels.

Pittsburgh Sleep Quality Index: Measurement of the quality and patterns of sleep from poor to good measuring seven domains (e.g., latency, duration, disturbances) over the last 2 weeks. Participants' scores are reported as a global score of the summed seven component scores together ranging from 0 to 21, where higher scores indicate worse sleep and a global score of 5 or above indicates poor sleep quality.

Times per day of cannabis flower use from 0 to 6. Includes all participants in Study A and only cannabis users in Study B.

This is a self-report scale based on DSM-5 criteria to assess dependence and other problems related to the use of cannabis. Scores are reported as a sum across the 11 items with yes/no options, ranging from 0 to 11, with higher scores indicating more dependence symptoms. Includes all participants in Study A and only cannabis users in Study B.

A 15-item scale used to collect information on withdrawal symptoms that participants may be experiencing due to the lack of use of marijuana. Options range from 0 (none) to 3 (severe) for each question and are summed to create a final score ranging from 0 to 45. Includes all participants in Study A and only cannabis users in Study B.

Standardized assessment of the extent of alcohol use and problems related to alcohol use. Scores are summed and range from 0 to 40 with higher scores indicating more hazardous alcohol use.

Calendar-based assessment of daily substance use for the 30 days prior to the baseline session for both studies. The average days of smoked cannabis use in the last 30 days are reported.

The SF-12 Health Survey is a 12-item questionnaire used to assess general health and well-being and includes domains of physical functioning, role-physical, pain, general health, vitality, social functioning, role-emotional and mental health. Only the mental component was analyzed. Scores are calculated using a weighted algorithm with scores ranging from 0 to 100; scores greater than 50 meaning better than average health and scores worse than 50 meaning worse than average health.

Interviewer administered recall measure developed by the University of Minnesota Nutrition Coordinating Center (NCC), that facilitates the standardized collection of 24-hour dietary recall data. Healthy Eating Index (HEI) total scores are reported for each participant, which is a measure of healthy eating on a scale of 0 (poor eating) to 100 (very healthy eating). Scores above 80 indicate a good diet, and scores below 80 indicate a diet in need of improvement.

Self-report measure of a single item comprising six descriptive categories ranging from inactive (1) to very active (6).

Daily surveys sent to Study B participants during the four-week period between study visits querying alcohol use. This is reported as average number of drinks/day of alcohol use.

Daily surveys sent to Study B participants during the four-week period between study visits querying minutes of exercise. This is reported as average minutes/day on exercise days.

Daily surveys sent to Study B participants during the four-week period between study visits querying consumption of fruits and vegetables. This is reported as average servings/day on fruit/vegetable consumption days.

Daily surveys sent to Study B participants during the four-week period between study visits querying amount of cannabis used. This is reported as average grams/cannabis use day.