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

Metabolic Syndrome Clinical Trial

— THCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574049
• Other study ID #: Weight Loss with THCV
• Status: Completed
• Phase: Early Phase 1
• Start date: January 4, 2022
• Est. completion date: May 4, 2022

Study information

• Verified date: October 2022
• Source: Medical Life Care Planners, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperglycemia
• Metabolic Syndrome
• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Drug:
• Tetrahydrocannabivarin
The subjects will take once daily oromucosal strip with intervention drug for 90 days.

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

Locations

Country	Name	City	State
United States	Hair and Scalp Clinic	Clearwater	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medical Life Care Planners, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Change in body weight measured in kilograms	90 days
Primary	Decreased abdominal girth	Change in abdominal girth measures in centimeters	90 days
Primary	Systolic and diastolic blood pressure	Changes in systolic and diastolic blood pressure	90 days
Secondary	Aspartate Aminotransferase (AST) changes	Change in AST level in blood tests	90 days
Secondary	Alanine Transaminase (ALT) changes	Change in ALT level in blood tests	90 days