Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
NCT05574049 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2022-10-10
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.
Conditions
- Metabolic Syndrome
- Morbid Obesity
- Hypercholesterolemia
- Hyperglycemia
Interventions
- 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
Sponsors & Collaborators
-
Medical Life Care Planners, LLC
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-04
- Primary Completion
- 2022-05-04
- Completion
- 2022-05-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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