Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
- Conditions
- Morbid ObesityHypercholesterolemiaHyperglycemiaMetabolic Syndrome
- Interventions
- Other: Placebo
- Registration Number
- NCT05574049
- Lead Sponsor
- Medical Life Care Planners, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease were selected for this study.
Under age 18 BMI less than 30 presence of diabetes or cardiovascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Dose Tetrahydrocannabivarin Once daily mouth strip containing 8mg of THCV and 10mg of CBD Single Dose Placebo Once daily mouth strip containing 8mg of THCV and 10mg of CBD Double Dose Tetrahydrocannabivarin Once daily mouth strip containing 16mg of THCV and 20mg of CBD Double Dose Placebo Once daily mouth strip containing 16mg of THCV and 20mg of CBD Placebo Tetrahydrocannabivarin Once daily mouth strip containing nothing
- Primary Outcome Measures
Name Time Method Decreased abdominal girth 90 days Change in abdominal girth measures in centimeters
Weight Loss 90 days Change in body weight measured in kilograms
Systolic and diastolic blood pressure 90 days Changes in systolic and diastolic blood pressure
- Secondary Outcome Measures
Name Time Method Aspartate Aminotransferase (AST) changes 90 days Change in AST level in blood tests
Alanine Transaminase (ALT) changes 90 days Change in ALT level in blood tests
Trial Locations
- Locations (1)
Hair and Scalp Clinic
🇺🇸Clearwater, Florida, United States