The Acute Effect of Vaping on Food Intake

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04219189

Enrollment

Registered

2020-01-06

Start date

2021-09-22

Completion date

2022-09-21

Last updated

2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Detailed 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.

Interventions

OTHERControl condition

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

OTHERVaping 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Energy Intake	intake was assessed over a 30 minute meal	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).

Secondary

Measure	Time frame	Description
Dietary Added Sugar Intake	intake was assessed over a 30 minute meal	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.
Dietary Sugar Intake	intake was assessed over a 30 minute meal	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.
Dietary Fat Intake	intake was assessed over a 30 minute meal	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.
Dietary Carbohydrate Intake	intake was assessed over a 30 minute meal	Dietary carbohydrate intake
Dietary Protein Intake	intake was assessed over a 30 minute meal	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.
Dietary Calcium Intake	intake was assessed over a 30 minute meal	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.
Dietary Cholesterol Intake	intake was assessed over a 30 minute meal	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.
Dietary Fiber Intake	intake was assessed over a 30 minute meal	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.
Dietary Iron Intake	intake was assessed over a 30 minute meal	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.
Dietary Potassium Intake	intake was assessed over a 30 minute meal	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.
Dietary Sodium Intake	intake was assessed over a 30 minute meal	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.
Dietary Saturated Fat Intake	intake was assessed over a 30 minute meal	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.
Dietary Vitamin D Intake	intake was assessed over a 30 minute meal	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.
Difference in Food Cravings	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.	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Vaping to Control Group Participants in this arm will undergo the vaping condition during the first visit and the control condition during the second visit. 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.	18
Control to Vaping Group Participants in this arm will undergo the control condition during the first visit and the vaping condition during the second visit. 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.	16
Total	34

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	1
Overall Study	Participant blood pressure out of range for the study , withdrawn by PI	0	1
Overall Study	Protocol Violation	0	1
Overall Study	Withdrawal by Subject	1	2

Baseline characteristics

Characteristic	Total	Control to Vaping Group	Vaping to Control Group
Age, Continuous	25.7 years STANDARD_DEVIATION 8.4	26.9 years STANDARD_DEVIATION 10.1	24.6 years STANDARD_DEVIATION 6.7
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	5 Participants	4 Participants	1 Participants
Race/Ethnicity, Customized Black or African American	5 Participants	1 Participants	4 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants	2 Participants	3 Participants
Race/Ethnicity, Customized Middle Eastern	4 Participants	1 Participants	3 Participants
Race/Ethnicity, Customized More than one race	3 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	29 Participants	14 Participants	15 Participants
Race/Ethnicity, Customized Prefer to self describe	2 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Unknown ethnicity or not reported	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Unknown or not reported	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White	15 Participants	7 Participants	8 Participants
Sex/Gender, Customized Female	12 Participants	7 Participants	5 Participants
Sex/Gender, Customized Male	21 Participants	9 Participants	12 Participants
Sex/Gender, Customized Non-Binary	1 Participants	0 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 18	0 / 16
other Total, other adverse events	1 / 18	0 / 16
serious Total, serious adverse events	0 / 18	0 / 16

Outcome results

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).