The Acute Effect of Vaping on Food Intake

NCT04219189 | Completed Results

• 3 other identifiers: HM200183822019-066-PBRCU54DA036105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Dietary Added Sugar Intake

  intake was assessed over a 30 minute meal

• Dietary Sugar Intake

  intake was assessed over a 30 minute meal

• Dietary Fat Intake

  intake was assessed over a 30 minute meal

• Dietary Carbohydrate Intake

  intake was assessed over a 30 minute meal

• Dietary Protein Intake

  intake was assessed over a 30 minute meal

Study Arms (2)

Vaping to Control Group

EXPERIMENTAL

Participants in this arm will undergo the vaping condition during the first visit and the control condition during the second visit.

Other: Vaping condition; Other: Control condition

Control to Vaping Group

EXPERIMENTAL

Participants in this arm will undergo the control condition during the first visit and the vaping condition during the second visit.

Other: Vaping condition; Other: Control condition

Interventions

Vaping condition OTHER

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 to Vaping Group; Vaping to Control Group

Control condition OTHER

Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.

Control to Vaping Group; Vaping to Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Pennington Biomedical Research Center: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for the Study of Tobacco Products

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Results Point of Contact

• Title: Dr. Caroline Cobb
• Organization: Virginia Commonwealth University

cobbco@vcu.edu

(804) 827-3562

Study Officials

• Caroline Cobb (Amey), PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 6, 2020
• Study Start: September 22, 2021
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: December 5, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)