Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the efficacy of two different daily doses of tetrahydrocannabivarin impregnated mouth strips in healthy non-diabetic obese adults. The main questions to answer are: Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels? Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels? Is one dose better than the other dose? Participants will take either the low dose, high dose or placebo dose daily for ninety days and have physical measurements and blood tests obtained at the beginning and the end of the study.

Detailed Description
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Fifty-six adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease will be selected for this study. Social media outreach and advertising will be used to identify potential subjects. Prior to starting the study, all subjects will undergo an entrance examination by a blinded independent physician to confirm that they did not have diabetes, active cardiovascular disease, or other confounding health conditions. Initial and final biometric measurements will be taken to include blood pressure, blood oxygen, temperature, height, weight, and abdominal girth. Due to the natural fluctuations in weight, abdominal girth and blood pressure that tend to occur throughout the menstrual cycle, those study participants with active menstrual periods will be scheduled to have their ending biometrics taken during the same phase of their menstrual cycle as when they had their initial biometrics taken, approximately 90 days later. Fasting bloodwork will include a lipid profile, blood sugar, HgbA1c, liver and kidney function studies. LabCorp Inc. will be used for all blood testing. Each subject will assigned at random to one of three groups: Group A (single dose group), Group B (double dose group,) and Group P (placebo/control group). Subjects will be provided with a 90-day supply of their respective dose (based on group assignment), and instructed to take their assigned dose by mouth, once per day in the morning on an empty stomach. All subjects will be asked to agreed from the outset to refrain from the use of cannabis, CBD, or other hemp-related products throughout the duration of the study. Subjects will be advised to make no changes in their diet or exercise routines. Each subject will be sent a daily reminder via text message when it was time to take their dose, and was asked to reply with confirmation once they had taken their dose. Additionally, they will be invited to provide feedback on any adverse effects or questions.

Official Title
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Weight Loss and Therapeutic Metablic Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips

Conditions
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Metabolic Syndrome, Morbid Obesity, Hypercholesterolemia, Hyperglycemia

Intervention / Treatment
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* Drug: Tetrahydrocannabivarin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease were selected for this study. Exclusion Criteria: Under age 18 BMI less than 30 presence of diabetes or cardiovascular disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be divided into three groups for daily doses. One group with get single dose (8mg THCV/10mg CBD), one group will get double dose (16mg THCV/20mg CBD) and the placebo group will get mouth strip only.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Dose<br>Once daily mouth strip containing 8mg of THCV and 10mg of CBD | Drug: Tetrahydrocannabivarin<br>* The subjects will take once daily oromucosal strip with intervention drug for 90 days.<br>* Other names: THCV;Other: Placebo<br>* The subjects will take once daily oromucosal strip with no drug on it for 90 days<br>* Other names: Plain mucoadhesive mouth strip;|
| Active Comparator: Double Dose<br>Once daily mouth strip containing 16mg of THCV and 20mg of CBD | Drug: Tetrahydrocannabivarin<br>* The subjects will take once daily oromucosal strip with intervention drug for 90 days.<br>* Other names: THCV;Other: Placebo<br>* The subjects will take once daily oromucosal strip with no drug on it for 90 days<br>* Other names: Plain mucoadhesive mouth strip;|
| Placebo Comparator: Placebo<br>Once daily mouth strip containing nothing | Drug: Tetrahydrocannabivarin<br>* The subjects will take once daily oromucosal strip with intervention drug for 90 days.<br>* Other names: THCV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Change in body weight measured in kilograms | 90 days | 
| Decreased abdominal girth | Change in abdominal girth measures in centimeters | 90 days | 
| Systolic and diastolic blood pressure | Changes in systolic and diastolic blood pressure | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspartate Aminotransferase (AST) changes | Change in AST level in blood tests | 90 days | 
| Alanine Transaminase (ALT) changes | Change in ALT level in blood tests | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tetrahydrocannabivarin, cannabidiol, metabolic syndrome, endocannabinoid system, cannabinoid one receptor