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

NCT ID: NCT05574049

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2022-05-04

Brief Summary

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

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.

Conditions

Metabolic Syndrome; Morbid Obesity; Hypercholesterolemia; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single Dose

Once daily mouth strip containing 8mg of THCV and 10mg of CBD

Group Type: ACTIVE_COMPARATOR

Tetrahydrocannabivarin

Intervention Type: DRUG

The subjects will take once daily oromucosal strip with intervention drug for 90 days.

Placebo

Intervention Type: OTHER

The subjects will take once daily oromucosal strip with no drug on it for 90 days

Double Dose

Once daily mouth strip containing 16mg of THCV and 20mg of CBD

Group Type: ACTIVE_COMPARATOR

Tetrahydrocannabivarin

Intervention Type: DRUG

The subjects will take once daily oromucosal strip with intervention drug for 90 days.

Placebo

Intervention Type: OTHER

The subjects will take once daily oromucosal strip with no drug on it for 90 days

Placebo

Once daily mouth strip containing nothing

Group Type: PLACEBO_COMPARATOR

Tetrahydrocannabivarin

Intervention Type: DRUG

The subjects will take once daily oromucosal strip with intervention drug for 90 days.

Interventions

Tetrahydrocannabivarin

The subjects will take once daily oromucosal strip with intervention drug for 90 days.

Intervention Type: DRUG

Placebo

The subjects will take once daily oromucosal strip with no drug on it for 90 days

Intervention Type: OTHER

Other Intervention Names

THCV; Plain mucoadhesive mouth strip

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Life Care Planners, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hair and Scalp Clinic

Clearwater, Florida, United States

Countries

United States

Other Identifiers

Weight Loss with THCV

Identifier Type: -

Identifier Source: org_study_id