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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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Florida
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Clearwater, Florida, États-Unis, 33762
- Hair and Scalp Clinic
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
Autres noms:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Autres noms:
|
|
Comparateur actif: 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.
Autres noms:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Autres noms:
|
|
Comparateur placebo: Placebo
Once daily mouth strip containing nothing
|
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Weight Loss
Délai: 90 days
|
Change in body weight measured in kilograms
|
90 days
|
|
Decreased abdominal girth
Délai: 90 days
|
Change in abdominal girth measures in centimeters
|
90 days
|
|
Systolic and diastolic blood pressure
Délai: 90 days
|
Changes in systolic and diastolic blood pressure
|
90 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Aspartate Aminotransferase (AST) changes
Délai: 90 days
|
Change in AST level in blood tests
|
90 days
|
|
Alanine Transaminase (ALT) changes
Délai: 90 days
|
Change in ALT level in blood tests
|
90 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Suralimentation
- Troubles nutritionnels
- En surpoids
- Poids
- Résistance à l'insuline
- Hyperinsulinisme
- Changements de poids corporel
- Troubles du métabolisme lipidique
- Hyperlipidémies
- Dyslipidémies
- Obésité
- Hyperglycémie
- Syndrome métabolique
- Perte de poids
- Hypercholestérolémie
- Obésité morbide
Autres numéros d'identification d'étude
- Weight Loss with THCV
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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