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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Vroege fase 1
Contacten en locaties
Studie Locaties
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Florida
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Clearwater, Florida, Verenigde Staten, 33762
- Hair and Scalp Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
Andere namen:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Andere namen:
|
|
Actieve vergelijker: 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.
Andere namen:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Andere namen:
|
|
Placebo-vergelijker: Placebo
Once daily mouth strip containing nothing
|
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Weight Loss
Tijdsspanne: 90 days
|
Change in body weight measured in kilograms
|
90 days
|
|
Decreased abdominal girth
Tijdsspanne: 90 days
|
Change in abdominal girth measures in centimeters
|
90 days
|
|
Systolic and diastolic blood pressure
Tijdsspanne: 90 days
|
Changes in systolic and diastolic blood pressure
|
90 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Aspartate Aminotransferase (AST) changes
Tijdsspanne: 90 days
|
Change in AST level in blood tests
|
90 days
|
|
Alanine Transaminase (ALT) changes
Tijdsspanne: 90 days
|
Change in ALT level in blood tests
|
90 days
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Glucosemetabolismestoornissen
- Metabole ziekten
- Overvoeding
- Voedingsstoornissen
- Overgewicht
- Lichaamsgewicht
- Insuline-resistentie
- Hyperinsulinisme
- Veranderingen in lichaamsgewicht
- Stoornissen in het metabolisme van lipiden
- Hyperlipidemie
- Dyslipidemie
- Obesitas
- Hyperglykemie
- Metaboolsyndroom
- Gewichtsverlies
- Hypercholesterolemie
- Obesitas, morbide
Andere studie-ID-nummers
- Weight Loss with THCV
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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