Trial Outcomes & Findings for The Acute Effect of Vaping on Food Intake (NCT NCT04219189)
NCT ID: NCT04219189
Last Updated: 2023-12-05
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
intake was assessed over a 30 minute meal
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Participant blood pressure out of range for the study , withdrawn by PI
|
0
|
1
|
Baseline Characteristics
The Acute Effect of Vaping on Food Intake
Baseline characteristics by cohort
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.6 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer to self describe
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown ethnicity or not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: intake was assessed over a 30 minute mealEnergy 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).
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Energy Intake
Kilocalories (active )
|
1102.1 Kilocalories
Standard Deviation 615.3
|
1003.4 Kilocalories
Standard Deviation 577.5
|
|
Energy Intake
Kilocalories (control)
|
910.4 Kilocalories
Standard Deviation 529.4
|
868.3 Kilocalories
Standard Deviation 443.6
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Added Sugar Intake
Added Sugar (active)
|
28.4 grams
Standard Deviation 27.5
|
43.0 grams
Standard Deviation 28.9
|
|
Dietary Added Sugar Intake
Added sugar (control)
|
25.0 grams
Standard Deviation 19.7
|
37.7 grams
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Sugar Intake
Sugar (active)
|
32.9 grams
Standard Deviation 28.0
|
54.0 grams
Standard Deviation 41.3
|
|
Dietary Sugar Intake
Sugar (control)
|
29.2 grams
Standard Deviation 20.1
|
50.0 grams
Standard Deviation 38.0
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Fat Intake
Fat (active)
|
40.9 grams
Standard Deviation 27.6
|
52.9 grams
Standard Deviation 27.6
|
|
Dietary Fat Intake
Fat (control)
|
37.7 grams
Standard Deviation 24.3
|
51.2 grams
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary carbohydrate intake
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Carbohydrate Intake
Carb (active)
|
82.2 grams
Standard Deviation 51.8
|
106.6 grams
Standard Deviation 62.0
|
|
Dietary Carbohydrate Intake
Carb (control)
|
72.8 grams
Standard Deviation 34.8
|
105.3 grams
Standard Deviation 55.1
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Protein Intake
Protein (active)
|
51.7 grams
Standard Deviation 33.7
|
58.3 grams
Standard Deviation 34.1
|
|
Dietary Protein Intake
Protein (control)
|
46.7 grams
Standard Deviation 29.0
|
53.1 grams
Standard Deviation 34.1
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Calcium Intake
Calcium (active)
|
287.1 milligrams
Standard Deviation 332.5
|
404.5 milligrams
Standard Deviation 269.8
|
|
Dietary Calcium Intake
Calcium (control)
|
294.4 milligrams
Standard Deviation 294.9
|
404.2 milligrams
Standard Deviation 349.2
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Cholesterol Intake
Cholesterol (control)
|
113.1 milligrams
Standard Deviation 75.7
|
146.3 milligrams
Standard Deviation 112.9
|
|
Dietary Cholesterol Intake
Cholesterol (active)
|
121.0 milligrams
Standard Deviation 82.3
|
143.2 milligrams
Standard Deviation 103.8
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Fiber Intake
Fiber (active)
|
3.2 grams
Standard Deviation 2.6
|
4.4 grams
Standard Deviation 3.9
|
|
Dietary Fiber Intake
Fiber (control)
|
3.2 grams
Standard Deviation 2.6
|
4.9 grams
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Iron Intake
Iron (active)
|
2.9 milligrams
Standard Deviation 1.7
|
3.3 milligrams
Standard Deviation 2.5
|
|
Dietary Iron Intake
Iron (control)
|
2.5 milligrams
Standard Deviation 1.3
|
3.5 milligrams
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Potassium Intake
Potassium (active)
|
606.4 milligrams
Standard Deviation 304.1
|
739.1 milligrams
Standard Deviation 470.5
|
|
Dietary Potassium Intake
Potassium (control)
|
544.4 milligrams
Standard Deviation 222.9
|
808.6 milligrams
Standard Deviation 509.2
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Sodium Intake
Sodium (active)
|
2045.5 milligrams
Standard Deviation 1215.1
|
2350.4 milligrams
Standard Deviation 1393.2
|
|
Dietary Sodium Intake
Sodium (control)
|
1865.3 milligrams
Standard Deviation 1047.6
|
2255.8 milligrams
Standard Deviation 1376.1
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Saturated Fat Intake
Sat_Fat (active)
|
14.5 grams
Standard Deviation 13.2
|
19.5 grams
Standard Deviation 11.5
|
|
Dietary Saturated Fat Intake
Sat_Fat (control)
|
13.6 grams
Standard Deviation 9.8
|
18.4 grams
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: intake was assessed over a 30 minute mealDietary 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Dietary Vitamin D Intake
Vit D (active)
|
0.16 mcg
Standard Deviation 0.22
|
0.25 mcg
Standard Deviation 0.22
|
|
Dietary Vitamin D Intake
Vit D (control)
|
0.16 mcg
Standard Deviation 0.20
|
0.25 mcg
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Vaping to Control Group
n=18 Participants
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.
|
Control to Vaping Group
n=16 Participants
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.
|
|---|---|---|
|
Difference in Food Cravings
Total FCQ (active)
|
49.8 units on a scale
Standard Deviation 10.6
|
48.7 units on a scale
Standard Deviation 8.4
|
|
Difference in Food Cravings
Total FCQ (control)
|
46.5 units on a scale
Standard Deviation 12.3
|
52.2 units on a scale
Standard Deviation 10.0
|
Adverse Events
Vaping to Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control to Vaping Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaping to Control Group
n=18 participants at risk
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.
|
Control to Vaping Group
n=16 participants at risk
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.
|
|---|---|---|
|
General disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/16 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place