An interventional study of Vaping condition and Control condition in Energy Intake, Food Intake and E-Cig Use, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Other
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.
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.
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).
Time frame: intake was assessed over a 30 minute meal
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.
Time frame: 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.
Time frame: 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.
Time frame: intake was assessed over a 30 minute meal
Dietary Carbohydrate Intake
Dietary carbohydrate intake
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
| Milestone | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Started | 19 | 21 |
| Completed | 18 | 16 |
| Not completed | 1 | 5 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Participant blood pressure out of range for the study , withdrawn by pi | 0 | 1 |
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).
| Kilocalories | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Kilocalories (active ) | 1102.1 ± 615.3 | 1003.4 ± 577.5 |
| Kilocalories (control) | 910.4 ± 529.4 | 868.3 ± 443.6 |
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.
| grams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Added Sugar (active) | 28.4 ± 27.5 | 43.0 ± 28.9 |
| Added sugar (control) | 25.0 ± 19.7 | 37.7 ± 24.4 |
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.
| grams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Sugar (active) | 32.9 ± 28.0 | 54.0 ± 41.3 |
| Sugar (control) | 29.2 ± 20.1 | 50.0 ± 38.0 |
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.
| grams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Fat (active) | 40.9 ± 27.6 | 52.9 ± 27.6 |
| Fat (control) | 37.7 ± 24.3 | 51.2 ± 28.4 |
Dietary carbohydrate intake
| grams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Carb (active) | 82.2 ± 51.8 | 106.6 ± 62.0 |
| Carb (control) | 72.8 ± 34.8 | 105.3 ± 55.1 |
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.
| grams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Protein (active) | 51.7 ± 33.7 | 58.3 ± 34.1 |
| Protein (control) | 46.7 ± 29.0 | 53.1 ± 34.1 |
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.
| milligrams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Calcium (active) | 287.1 ± 332.5 | 404.5 ± 269.8 |
| Calcium (control) | 294.4 ± 294.9 | 404.2 ± 349.2 |
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.
| milligrams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Cholesterol (active) | 121.0 ± 82.3 | 143.2 ± 103.8 |
| Cholesterol (control) | 113.1 ± 75.7 | 146.3 ± 112.9 |
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.
| grams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Fiber (active) | 3.2 ± 2.6 | 4.4 ± 3.9 |
| Fiber (control) | 3.2 ± 2.6 | 4.9 ± 4.3 |
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.
| milligrams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Iron (active) | 2.9 ± 1.7 | 3.3 ± 2.5 |
| Iron (control) | 2.5 ± 1.3 | 3.5 ± 2.4 |
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.
| milligrams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Potassium (active) | 606.4 ± 304.1 | 739.1 ± 470.5 |
| Potassium (control) | 544.4 ± 222.9 | 808.6 ± 509.2 |
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.
| milligrams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Sodium (active) | 2045.5 ± 1215.1 | 2350.4 ± 1393.2 |
| Sodium (control) | 1865.3 ± 1047.6 | 2255.8 ± 1376.1 |
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.
| grams | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Sat_Fat (active) | 14.5 ± 13.2 | 19.5 ± 11.5 |
| Sat_Fat (control) | 13.6 ± 9.8 | 18.4 ± 12.3 |
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.
| mcg | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Vit D (active) | 0.16 ± 0.22 | 0.25 ± 0.22 |
| Vit D (control) | 0.16 ± 0.20 | 0.25 ± 0.30 |
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.
| units on a scale | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| Total FCQ (active) | 49.8 ± 10.6 | 48.7 ± 8.4 |
| Total FCQ (control) | 46.5 ± 12.3 | 52.2 ± 10.0 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaping to Control Group | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Control to Vaping Group | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Event | Vaping to Control Group | Control to Vaping Group |
|---|---|---|
| DizzinessGeneral disorders | 1/18 | 0/16 |
| Age, Continuous(years) | Vaping to Control Group | Control to Vaping Group | Total |
|---|---|---|---|
| Mean | 24.6 ± 6.7 | 26.9 ± 10.1 | 25.7 ± 8.4 |
| Sex/Gender, Customized(Participants) | Vaping to Control Group | Control to Vaping Group | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 12 | 9 | 21 |
| Non-Binary | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Vaping to Control Group | Control to Vaping Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Middle Eastern | 3 | 1 | 4 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 5 |
| Prefer to self describe | 1 | 1 | 2 |
| White | 8 | 7 | 15 |
| More than one race | 1 | 2 | 3 |
| Unknown or not reported | 0 | 0 | 0 |
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 15 | 14 | 29 |
| Unknown ethnicity or not reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Virginia Commonwealth University