- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05574049
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Tidig fas 1
Kontakter och platser
Studieorter
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Florida
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Clearwater, Florida, Förenta staterna, 33762
- Hair and Scalp Clinic
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
Andra namn:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Andra namn:
|
Aktiv komparator: 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.
Andra namn:
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Andra namn:
|
Placebo-jämförare: Placebo
Once daily mouth strip containing nothing
|
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weight Loss
Tidsram: 90 days
|
Change in body weight measured in kilograms
|
90 days
|
Decreased abdominal girth
Tidsram: 90 days
|
Change in abdominal girth measures in centimeters
|
90 days
|
Systolic and diastolic blood pressure
Tidsram: 90 days
|
Changes in systolic and diastolic blood pressure
|
90 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Aspartate Aminotransferase (AST) changes
Tidsram: 90 days
|
Change in AST level in blood tests
|
90 days
|
Alanine Transaminase (ALT) changes
Tidsram: 90 days
|
Change in ALT level in blood tests
|
90 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Övernäring
- Näringsstörningar
- Övervikt
- Kroppsvikt
- Insulinresistens
- Hyperinsulinism
- Förändringar i kroppsvikt
- Lipidmetabolismstörningar
- Hyperlipidemier
- Dyslipidemier
- Fetma
- Hyperglykemi
- Metaboliskt syndrom
- Viktminskning
- Hyperkolesterolemi
- Fetma, sjuklig
Andra studie-ID-nummer
- Weight Loss with THCV
Läkemedels- och apparatinformation, studiedokument
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Kliniska prövningar på Tetrahydrocannabivarin
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Jazz PharmaceuticalsAvslutadDiabetes mellitus, typ 2Storbritannien, Rumänien
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Jazz PharmaceuticalsAvslutadDiabetes mellitus, typ 2 | DyslipidemierStorbritannien
-
Gregory L Smith, MD, MPHRekryteringAndrogen alopeciFörenta staterna