Energy IntakeNCT04219189
The Acute Effect of Vaping on Food Intake
A study testing Vaping condition in people with Energy Intake and Food Intake, run by Virginia Commonwealth University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Intake, Food Intake, E-Cig Use
- What is being tested?
- Vaping condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 21 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Study of Tobacco Products
Richmond, Virginia, 23220
About this study
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
Read the 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.
- Conditions
- Energy Intake, Food Intake, E-Cig Use, Appetite
- Being tested
- Vaping condition, Control condition
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaping conditionOther
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 conditionOther
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Vaping condition; Other: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: intake was assessed over a 30 minute meal
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: intake was assessed over a 30 minute meal
Dietary Carbohydrate Intake
Dietary carbohydrate intake
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start22 Sep 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Energy IntakeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Caroline Cobb (Amey), PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219189
- Sponsor's protocol ID
- HM20018382
- Other IDs
- 2019-066-PBRC, U54DA036105
- Status last verified
- Nov 2023
- First submitted
- 3 Jan 2020
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Vaping on Food Intake
- ClinicalTrials.gov ID
- NCT04219189
- Acronym / sponsor ID
- HM20018382
- Conditions
- Energy Intake, Food Intake, E-Cig Use, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center, National Institute on Drug Abuse (NIDA)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vaping to Control Group | Experimental | Other: Vaping condition, Other: Control conditionParticipants in this arm will undergo the vaping condition during the first visit and the control condition during the second visit. |
| Control to Vaping Group | Experimental | Other: Vaping condition, Other: Control conditionParticipants in this arm will undergo the control condition during the first visit and the vaping condition during the second visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaping conditionParticipants 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. | Other | Control to Vaping Group, Vaping to Control Group |
| Control conditionParticipants will have access to an uncharged JUUL device with an empty pod for 20 minutes. | Other | Control to Vaping Group, Vaping to Control Group |
Primary outcome
Energy Intake
Time frame: 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).
14 secondary outcomes
Dietary Added Sugar Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Sugar Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Fat Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Carbohydrate Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Protein Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Calcium Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Cholesterol Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Fiber Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Iron Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Potassium Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Sodium Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Saturated Fat Intake
Time frame: intake was assessed over a 30 minute meal
Dietary Vitamin D Intake
Time frame: intake was assessed over a 30 minute meal
Difference in Food Cravings
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Cobb (Amey), PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaping condition in people with Energy Intake and Food Intake, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Intake (time frame: intake was assessed over a 30 minute meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.