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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-066-PBRC | Other Identifier | Pennington Biomedical Research Center | |
| U54DA036105 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Pennington Biomedical Research Center | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Cobb (Amey), PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for the Study of Tobacco Products | Richmond | Virginia | 23220 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Kilocalories | intake was assessed over a 30 minute meal |
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Data were collected following enrollment (screening/baseline visit) until completion of the final session or last date of contact with the participant (if withdrawn). The typical length of the study participation was approximately 2-4 weeks.
At screening/baseline participants self-reported current physical symptoms and health conditions. Upon arrival to each study session, participants took a pre-session questionnaire to measure any changes in health since the previous in-person visit. Participants could also spontaneously report changes in health.
Of note - the only AE observed for the Vaping to Control Group occurred during the Vaping (active) condition and was spontaneously reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Please note, due to the way the arms/groups were described originally in clinicaltrials.gov, reporting for these outcomes is provided by condition order not by individual intervention or arm. Please see additional detail for the adverse event described above. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caroline Cobb | Virginia Commonwealth University | (804) 827-3562 | cobbco@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2023 | Oct 12, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2022 | Oct 10, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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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.
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| Control condition | Other | Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes. |
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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. |
| Lost to Follow-up |
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| Participant blood pressure out of range for the study , withdrawn by PI |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 |
| 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. |
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| 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. | Posted | Mean | Standard Deviation | grams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | grams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | grams | intake was assessed over a 30 minute meal |
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| Secondary | Dietary Carbohydrate Intake | Dietary carbohydrate intake | Posted | Mean | Standard Deviation | grams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | grams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | milligrams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | milligrams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | grams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | milligrams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | milligrams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | milligrams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | grams | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | mcg | intake was assessed over a 30 minute meal |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | 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. Please note, due to the way the arms/groups were described originally in clinicaltrials.gov, reporting for these outcomes is provided by condition order not by individual intervention or arm. Please see additional detail for the adverse event described above. | 0 | 16 | 0 | 16 | 0 | 16 |
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