Appetite Clinical Trial
Official title:
The Acute Effect of Vaping on Food Intake
Verified date | November 2023 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assesses the acute effects of a standardized 20-minute vaping episode compared to a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal, occurring approximately 45 minutes after the vaping episode
Status | Completed |
Enrollment | 40 |
Est. completion date | September 21, 2022 |
Est. primary completion date | September 21, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18 - 65 years of age (ID card verified) - Reports either everyday e-cigarette use with liquid containing at least 0.3% (~3 mg/ml) nicotine or some day e-cigarette use ( at least 3 days a week) with liquid containing at least 3% (~30 mg/ml) nicotine for the past 30 days. Exclusion Criteria: - being unwilling to consume the foods provided due to: a) dietary limitations or preferences or b) allergies to the foods provided. - being unwilling to take 20 puffs from a JUUL device containing a 5% nicotine pod - self-reported current, diagnosed medical condition(s) will be excluded automatically: heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures - observed high blood pressure at screening (systolic >140; diastolic >90) - other self-reported current, diagnosed medical conditions (e.g., specific food allergies, diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor - self-reported current, diagnosed psychiatric conditions or who report current psychiatric treatment or psychotropic medication use - past month use of cocaine, opioids, benzodiazepines, methamphetamine, or other (non-cannabis) illicit drugs - self-report of >25 days out of the past 30 for alcohol use or >20 days out of the past 30 for cannabis use. - women who are breast-feeding or test positive for pregnancy (by urinalysis at screening) - women using progestin-IUDS for birth control - women using birth control injections (e.g., Depo-Provera) - women who received a hysterectomy and still have ovaries present - self-report intending to quit tobacco/nicotine products in the next 30 days |
Country | Name | City | State |
---|---|---|---|
United States | Center for the Study of Tobacco Products | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | National Institute on Drug Abuse (NIDA), Pennington Biomedical Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Energy Intake | Energy intake in kilocalories (kcal) during the ad libitum buffet meal will be measured via directly weighed food provision and waste (food/energy intake is calculated by difference). | intake was assessed over a 30 minute meal | |
Secondary | Dietary Added Sugar Intake | Dietary added sugar intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Sugar Intake | Dietary sugar intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Fat Intake | Dietary fat intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Carbohydrate Intake | Dietary carbohydrate intake | intake was assessed over a 30 minute meal | |
Secondary | Dietary Protein Intake | Dietary protein intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Calcium Intake | Dietary calcium intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Cholesterol Intake | Dietary cholesterol intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Fiber Intake | Dietary fiber intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Iron Intake | Dietary iron intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Potassium Intake | Dietary potassium intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Sodium Intake | Dietary sodium intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Saturated Fat Intake | Dietary saturated fat intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Dietary Vitamin D Intake | Dietary Vitamin D Intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. | intake was assessed over a 30 minute meal | |
Secondary | Difference in Food Cravings | Total score in the Food Cravings Questionnaire State (FCQ-State) after the vaping vs after the non-vaping condition. Fifteen items are rated on a 5-point Likert Scale (Strongly Disagree=1, Disagree=2, Neutral=3, Agree=4, Strongly Agree=5) with higher scores indicating higher food cravings. For a total score, all 15 items were summed together and higher scores indicate a higher intensity or craving to eat (Meule, 2020). The range for total scores is around 15-75. | The FCQ-State was administered about 30 minutes after either the vaping or non-vaping (control) condition and about ~20 minutes before the ad lib buffet meal. |
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