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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Metabolic Syndrome; Hypercholesterolemia; Morbid Obesity
• Intervention / Treatment: Drug: Tetrahydrocannabivarin; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33762
      • Hair and Scalp Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical Life Care Planners, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: metabolic syndrome; cannabidiol; tetrahydrocannabivarin; endocannabinoid system; cannabinoid one receptor
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Body Weight Changes; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Obesity; Hyperglycemia; Metabolic Syndrome; Weight Loss; Hypercholesterolemia; Obesity, Morbid
• Other Study ID Numbers: Weight Loss with THCV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No