Trial Outcomes & Findings for The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents (NCT NCT01192100)
NCT ID: NCT01192100
Last Updated: 2020-04-03
Results Overview
Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days beginning at baseline and about every 30 minutes for a total of 20 questionnaires (- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min). The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated by computing the summation of the average change from baseline score (mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures. For reported feelings of hunger, a higher score can be interpreted as "feeling more hungry" throughout the day. This can be applied to the three other perceived sensations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
5 weeks
Results posted on
2020-04-03
Participant Flow
Participant milestones
| Measure |
Normal Protein > High Protein > Skip
6 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat); 2) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat); and 3) Breakfast Skipping. On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
Skip > Normal Protein > High Protein
4 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat) and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
Skip > High Protein > Normal Protein
3 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat), and 3) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
High Protein > Skip > Normal Protein
4 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat), 2) Breakfast Skipping and 3) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern
|
High Protein > Normal Protein > Skip
3 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat), 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat) and 3) Breakfast Skipping. On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
Normal Protein > Skip > High Protein
2 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat), 2) Breakfast Skipping and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
3
|
4
|
3
|
2
|
|
Overall Study
Began 1st Intervention Week
|
6
|
4
|
3
|
4
|
3
|
2
|
|
Overall Study
Began 2nd Intervention Week
|
6
|
4
|
3
|
3
|
2
|
2
|
|
Overall Study
Began 3rd Intervention Week
|
6
|
4
|
3
|
3
|
2
|
2
|
|
Overall Study
COMPLETED
|
6
|
4
|
3
|
3
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Normal Protein > High Protein > Skip
6 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat); 2) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat); and 3) Breakfast Skipping. On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
Skip > Normal Protein > High Protein
4 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat) and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
Skip > High Protein > Normal Protein
3 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat), and 3) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
High Protein > Skip > Normal Protein
4 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat), 2) Breakfast Skipping and 3) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern
|
High Protein > Normal Protein > Skip
3 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat), 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat) and 3) Breakfast Skipping. On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
Normal Protein > Skip > High Protein
2 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in the following order, the follow breakfast patterns at home for 6 days: 1) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat), 2) Breakfast Skipping and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Baseline characteristics by cohort
| Measure |
All Study Participants
n=22 Participants
22 overweight 'breakfast skipping' adolescent girls participated in a randomized crossover-design breakfast study where they were completed, in a random order, the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals (i.e., 350 kcal; 15% protein, 65% CHO, \& 20% fat); and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% protein, 40% CHO, \& 20% fat). On the 7th day of each pattern, the participants reported to the testing facilities in the morning to complete the respective 10-h testing day. Blood samples and assessments of perceived appetite were collected/completed throughout the day following the breakfast (or no breakfast). A standardized lunch was also be provided. Prior to dinner, a brain scan was completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. There was a 7-day washout period between each breakfast pattern.
|
|---|---|
|
Age, Continuous
|
19 Years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 weeksComputerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days beginning at baseline and about every 30 minutes for a total of 20 questionnaires (- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min). The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated by computing the summation of the average change from baseline score (mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures. For reported feelings of hunger, a higher score can be interpreted as "feeling more hungry" throughout the day. This can be applied to the three other perceived sensations.
Outcome measures
| Measure |
Breakfast Skipping
n=20 Participants
Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.
Breakfast Skipping: Participants will continue to skip breakfast each morning.
|
Normal Protein Breakfast Meals
n=20 Participants
For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.
Normal Protein Breakfast Meals: Participants will consume normal protein breakfast meals each morning.
|
Protein-rich Breakfast Meals
n=20 Participants
For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.
Protein-rich Breakfast Meals: Participants will consume protein-rich breakfast meals each morning.
|
|---|---|---|---|
|
Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption
How strong is your feeling of hunger?
|
17000 mm*min
Standard Error 5000
|
11000 mm*min
Standard Error 3000
|
10000 mm*min
Standard Error 3000
|
|
Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption
How strong is your feeling of being full?
|
21000 mm*min
Standard Error 5000
|
27000 mm*min
Standard Error 6000
|
28000 mm*min
Standard Error 8000
|
|
Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption
How strong is your desire to eat?
|
18000 mm*min
Standard Error 5000
|
13000 mm*min
Standard Error 4000
|
12000 mm*min
Standard Error 4000
|
|
Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption
How much food can you eat right now?
|
17000 mm*min
Standard Error 6000
|
13000 mm*min
Standard Error 4000
|
10000 mm*min
Standard Error 3000
|
PRIMARY outcome
Timeframe: 5 weeksThe samples were collected in test tubes containing ethylenediaminetetraacetic acid. Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation. The plasma was separated and stored in microcentrifuge tubes at -80°C for future analysis. Plasma total ghrelin and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay and Magpix Luminex technologies. AUC was calculated by computing the summation of the average change from baseline score (pg/ml) for each time point and the subsequent time point multiplied by the difference in time (min) between the two time instances for a total of 20 blood samples (- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min).
Outcome measures
| Measure |
Breakfast Skipping
n=20 Participants
Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.
Breakfast Skipping: Participants will continue to skip breakfast each morning.
|
Normal Protein Breakfast Meals
n=20 Participants
For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.
Normal Protein Breakfast Meals: Participants will consume normal protein breakfast meals each morning.
|
Protein-rich Breakfast Meals
n=20 Participants
For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.
Protein-rich Breakfast Meals: Participants will consume protein-rich breakfast meals each morning.
|
|---|---|---|---|
|
Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY)
Ghrelin (10^3)
|
41 (pg*min)/ml
Standard Error 4
|
35 (pg*min)/ml
Standard Error 3
|
34 (pg*min)/ml
Standard Error 3
|
|
Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY)
Ln PYY
|
0 (pg*min)/ml
Standard Error 25
|
90 (pg*min)/ml
Standard Error 80
|
160 (pg*min)/ml
Standard Error 70
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: Coordinates were only determined for regions considered significant by analysis using Brain Voyager.
Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category were presented in blocks of images. Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing). To determine the effects of breakfast/no breakfast on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus \[food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing\]. To identify significant activations in a priori regions, a cluster level statistical threshold was applied to correct for multiple comparisons. By using this approach, significance was set at P = 0.01, with a cluster-level false-positive rate of a = 0.05
Outcome measures
| Measure |
Breakfast Skipping
n=20 Participants
Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.
Breakfast Skipping: Participants will continue to skip breakfast each morning.
|
Normal Protein Breakfast Meals
n=20 Participants
For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.
Normal Protein Breakfast Meals: Participants will consume normal protein breakfast meals each morning.
|
Protein-rich Breakfast Meals
For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.
Protein-rich Breakfast Meals: Participants will consume protein-rich breakfast meals each morning.
|
|---|---|---|---|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Amygdala (x)
|
-28 Talairach Coordinates
|
—
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Amygdala (y)
|
-5 Talairach Coordinates
|
—
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Amygdala (z)
|
-18 Talairach Coordinates
|
—
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Hippocampus (x)
|
-31 Talairach Coordinates
|
-19 Talairach Coordinates
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Hippocampus (y)
|
-11 Talairach Coordinates
|
-17 Talairach Coordinates
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Hippocampus (z)
|
-12 Talairach Coordinates
|
-18 Talairach Coordinates
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Middle Frontal Gyrus (x)
|
-25 Talairach Coordinates
|
—
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Middle Frontal Gyrus (y)
|
-8 Talairach Coordinates
|
—
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Middle Frontal Gyrus (z)
|
42 Talairach Coordinates
|
—
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Parahippocampus (x)
|
—
|
-28 Talairach Coordinates
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Parahippocampus (y)
|
—
|
-17 Talairach Coordinates
|
—
|
|
Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans
Parahippocampus (z)
|
—
|
-30 Talairach Coordinates
|
—
|
SECONDARY outcome
Timeframe: 5 weeksEnergy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured.
Outcome measures
| Measure |
Breakfast Skipping
n=20 Participants
Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.
Breakfast Skipping: Participants will continue to skip breakfast each morning.
|
Normal Protein Breakfast Meals
n=20 Participants
For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.
Normal Protein Breakfast Meals: Participants will consume normal protein breakfast meals each morning.
|
Protein-rich Breakfast Meals
n=20 Participants
For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.
Protein-rich Breakfast Meals: Participants will consume protein-rich breakfast meals each morning.
|
|---|---|---|---|
|
Daily Energy Intake
|
2002 kilocalories
Standard Error 111
|
2292 kilocalories
Standard Error 115
|
2123 kilocalories
Standard Error 71
|
Adverse Events
Breakfast Skipping
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Protein Breakfast Meals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Protein-rich Breakfast Meals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place