The Acute Effect of Vaping on Food Intake

Study Overview
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Brief Summary
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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

Detailed Description
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Weight control is a common motive for cigarette smoking and nicotine has been shown to suppress appetite and increase resting metabolic rate, and also serves as a behavioral alternative to eating or a distraction from hunger or food craving. Data on the acute effect of e-cigarette use ('vaping') on ad libitum food intake are non-existent. Given that many e-cigarette users report vaping for weight control and that certain e-cigarettes are being actively marketed for weight management and/or suppression of food cravings, addressing this research gap is of the utmost importance.

Official Title
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The Acute Effect of Vaping on Food Intake

Conditions
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Energy Intake, Food Intake, E-Cig Use, Appetite

Intervention / Treatment
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* Other: Vaping condition
* Other: Control condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study consists of a baseline assessment which is followed by two within-subject, laboratory conditions that differ by the product used: 1) JUUL e-cigarette with a 5% nicotine pod, 2) no active e-cigarette use (uncharged JUUL with empty pod). The condition orders (i.e., 1 then 2, or 2 then 1) will be randomly ordered and assigned following enrollment. During the vaping condition, participants will be asked to take 20 e-cigarette puffs over 20 minutes before consuming an ad libitum buffet meal. During the alternative control condition, participants will have access to an uncharged JUUL with an empty pod for 20 minutes (instead of vaping) before consuming an ad libitum buffet meal.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaping to Control Group<br>Participants in this arm will undergo the vaping condition during the first visit and the control condition during the second visit. | Other: Vaping condition<br>* Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with  5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.<br>Other: Control condition<br>* Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.<br>|
| Experimental: Control to Vaping Group<br>Participants in this arm will undergo the control condition during the first visit and the vaping condition during the second visit. | Other: Vaping condition<br>* Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with  5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.<br>Other: Control condition<br>* Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Dietary Carbohydrate Intake | Dietary carbohydrate intake | intake was assessed over a 30 minute meal | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. |