Trial Outcomes & Findings for Activity, Adiposity, and Appetite in Adolescents 2 (NCT NCT04028921)
NCT ID: NCT04028921
Last Updated: 2025-04-02
Results Overview
The investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal: Hunger, Area Under the Curve (AUC) Hunger and palatability were assessed using self-rated visual analogue scales (Rogers, P. J., \& Blundell, J. E. (1993). Intense sweeteners and appetite. The American Journal of Clinical Nutrition, 58(1), 120-122.) Scale is 0-100, with 0 equaling 'I am not hungry at all' and 100 equaling 'I have never been more hungry'. Area under the curve (AUC) was calculated for appetite variables by calculating the area of the response as you would a trapezoid.
Recruitment status
COMPLETED
Target enrollment
46 participants
Primary outcome timeframe
Baseline
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
Normal Weight, Active
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Normal Weight, Sedentary
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Active
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Sedentary
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
12
|
10
|
|
Overall Study
COMPLETED
|
13
|
11
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Activity, Adiposity, and Appetite in Adolescents 2
Baseline characteristics by cohort
| Measure |
Normal Weight, Active
n=13 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Normal Weight, Sedentary
n=11 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Active
n=12 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Sedentary
n=10 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
15.9 years
STANDARD_DEVIATION 0.3 • n=5 Participants
|
16.0 years
STANDARD_DEVIATION 0.4 • n=7 Participants
|
16.4 years
STANDARD_DEVIATION 0.4 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 0.4 • n=4 Participants
|
16.0 years
STANDARD_DEVIATION 0.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselineThe investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal: Hunger, Area Under the Curve (AUC) Hunger and palatability were assessed using self-rated visual analogue scales (Rogers, P. J., \& Blundell, J. E. (1993). Intense sweeteners and appetite. The American Journal of Clinical Nutrition, 58(1), 120-122.) Scale is 0-100, with 0 equaling 'I am not hungry at all' and 100 equaling 'I have never been more hungry'. Area under the curve (AUC) was calculated for appetite variables by calculating the area of the response as you would a trapezoid.
Outcome measures
| Measure |
Normal Weight, Active
n=13 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Normal Weight, Sedentary
n=11 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Active
n=12 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Sedentary
n=10 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
|---|---|---|---|---|
|
Appetite- Subjective
|
9239.4 score on a scale*min
Standard Deviation 3635.1
|
7879.6 score on a scale*min
Standard Deviation 5343.5
|
6130.5 score on a scale*min
Standard Deviation 4279.7
|
8970.0 score on a scale*min
Standard Deviation 3664.9
|
PRIMARY outcome
Timeframe: BaselinePopulation: Plasma ghrelin values were not assessed. Blood samples needed for assessment were not obtained due to lack of staff. Samples will not be collected in the future.
The investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselineThe investigators will measure objective and subjective appetite responses as described above adjusted by insulin sensitivity (glucose infusion rate, mg/kg/min) as assessed in the euglycemic hyperinsulinemic clamp technique. Hunger score on a scale\*min adjusted for glucose infusion rate (mL/kgFFM/min) and sex
Outcome measures
| Measure |
Normal Weight, Active
n=13 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Normal Weight, Sedentary
n=11 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Active
n=12 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Sedentary
n=10 Participants
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
|---|---|---|---|---|
|
Appetite- Adjusted
|
8686 score on a scale*min
Standard Deviation 1414
|
7885 score on a scale*min
Standard Deviation 1442
|
6534 score on a scale*min
Standard Deviation 1528
|
8703 score on a scale*min
Standard Deviation 1537
|
Adverse Events
Normal Weight, Active
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Normal Weight, Sedentary
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Overweight/Obese, Active
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Overweight/Obese, Sedentary
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Weight, Active
n=13 participants at risk
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Normal Weight, Sedentary
n=11 participants at risk
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Active
n=12 participants at risk
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \>=60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
Overweight/Obese, Sedentary
n=10 participants at risk
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \<60 min/day of moderate/vigorous physical activity.
No intervention: This is a cross-sectional study; no intervention
|
|---|---|---|---|---|
|
Vascular disorders
Extravasation of IV
|
0.00%
0/13 • Baseline
|
9.1%
1/11 • Number of events 1 • Baseline
|
0.00%
0/12 • Baseline
|
0.00%
0/10 • Baseline
|
|
Vascular disorders
Lightheadedness during IV placement
|
15.4%
2/13 • Number of events 2 • Baseline
|
9.1%
1/11 • Number of events 1 • Baseline
|
16.7%
2/12 • Number of events 2 • Baseline
|
10.0%
1/10 • Number of events 1 • Baseline
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place