The Acute Effect of Vaping on Food Intake

Appetite Clinical Trial

Official title:

The Acute Effect of Vaping on Food Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219189
• Other study ID #: HM20018382
• Secondary ID: 2019-066-PBRCU54
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: September 21, 2022

Study information

• Verified date: November 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Appetite
• E-Cig Use
• Energy Intake
• Food Intake

Intervention

Other:
• Vaping condition
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.
• Control condition
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.

Locations

Country	Name	City	State
United States	Center for the Study of Tobacco Products	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA), Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

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.