Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
Condition: Metabolic Syndrome; Morbid Obesity; Hypercholesterolemia; Hyperglycemia
MeSH terms: Metabolic Syndrome; Hypercholesterolemia; Hyperglycemia; Obesity, Morbid; Weight Loss
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Tetrahydrocannabivarin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The subjects will take once daily oromucosal strip with intervention drug for 90 days.; The subjects will take once daily oromucosal strip with no drug on it for 90 days
Other intervention name(s): THCV; Plain mucoadhesive mouth strip
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tetrahydrocannabivarin; cannabidiol; metabolic syndrome; endocannabinoid system; cannabinoid one receptor