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NCT Number: NCT05574049

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

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Dyslipidemias Glucose Metabolism Disorders Hypercholesterolemia Hyperglycemia Hyperinsulinism Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hair and Scalp Clinic

Clearwater, Florida, 33762, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tetrahydrocannabivarin

Drug

The subjects will take once daily oromucosal strip with intervention drug for 90 days.

Other names: THCV

Placebo

Other

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

Other names: Plain mucoadhesive mouth strip

Primary outcomes

  1. Weight Loss

    Time frame: 90 days

    Change in body weight measured in kilograms

  2. Decreased abdominal girth

    Time frame: 90 days

    Change in abdominal girth measures in centimeters

  3. Systolic and diastolic blood pressure

    Time frame: 90 days

    Changes in systolic and diastolic blood pressure

Secondary outcomes

  1. Aspartate Aminotransferase (AST) changes

    Time frame: 90 days

    Change in AST level in blood tests

  2. Alanine Transaminase (ALT) changes

    Time frame: 90 days

    Change in ALT level in blood tests

Sponsors and collaborators

Lead sponsor

Medical Life Care Planners, LLC

Other

Registry information

Official study title

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

Acronym: THCV

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2022
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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