Clinical trial NCT05574049: Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
Official title: Weight Loss and Therapeutic Metablic Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metabolic Syndrome
Morbid Obesity
Hypercholesterolemia
Hyperglycemia
Keywords: tetrahydrocannabivarin
cannabidiol
metabolic syndrome
endocannabinoid system
cannabinoid one receptor
Lead sponsor: Medical Life Care Planners, LLC
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Weight Loss
timeFrame: 90 days
measure: Decreased abdominal girth
timeFrame: 90 days
measure: Systolic and diastolic blood pressure
timeFrame: 90 days
Secondary outcomes:
measure: Aspartate Aminotransferase (AST) changes
timeFrame: 90 days
measure: Alanine Transaminase (ALT) changes
timeFrame: 90 days
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Hair and Scalp Clinic
state: Florida
Study officials:
References: