Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips (THCV)
Weight Loss and Therapeutic Metablic 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Clearwater, Florida, Estados Unidos, 33762
- Hair and Scalp Clinic
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Single Dose
Once daily mouth strip containing 8mg of THCV and 10mg of CBD
|
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
Otros nombres:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Otros nombres:
|
|
Comparador activo: Double Dose
Once daily mouth strip containing 16mg of THCV and 20mg of CBD
|
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
Otros nombres:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Otros nombres:
|
|
Comparador de placebos: Placebo
Once daily mouth strip containing nothing
|
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight Loss
Periodo de tiempo: 90 days
|
Change in body weight measured in kilograms
|
90 days
|
|
Decreased abdominal girth
Periodo de tiempo: 90 days
|
Change in abdominal girth measures in centimeters
|
90 days
|
|
Systolic and diastolic blood pressure
Periodo de tiempo: 90 days
|
Changes in systolic and diastolic blood pressure
|
90 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Aspartate Aminotransferase (AST) changes
Periodo de tiempo: 90 days
|
Change in AST level in blood tests
|
90 days
|
|
Alanine Transaminase (ALT) changes
Periodo de tiempo: 90 days
|
Change in ALT level in blood tests
|
90 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Sobrenutrición
- Trastornos Nutricionales
- Exceso de peso
- Peso corporal
- Resistencia a la insulina
- Hiperinsulinismo
- Cambios en el peso corporal
- Trastornos del metabolismo de los lípidos
- Hiperlipidemias
- Dislipidemias
- Obesidad
- Hiperglucemia
- Síndrome metabólico
- Pérdida de peso
- Hipercolesterolemia
- Obesidad Mórbida
Otros números de identificación del estudio
- Weight Loss with THCV
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .