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| Name | Class |
|---|---|
| American Egg Board | OTHER |
| National Cattlemen's Beef Association, a contractor to the Beef Checkoff | INDUSTRY |
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The purpose of this study is to assess whether the daily addition of a protein-rich breakfast leads to beneficial changes in appetite control, food intake regulation,and cognitive function in overweight & obese 'breakfast skipping' young women.
Breakfast skipping, which is a common, yet unhealthy dietary habit among young women, has been strongly associated with over-eating (especially in the evening), weight gain, and obesity. Breakfast skipping has also been shown to reduce cognitive function in this population. However, it is unclear as to whether the addition of breakfast, with specific emphasis on increased dietary protein, leads to improvements in these outcomes. This study will provide mechanistic evidence supporting the addition of a protein-rich breakfast to improve and/or re-establish appetite control, energy intake regulation, and cognitive function in overweight/obese 'breakfast skipping' young women. 22 overweight and obese 'breakfast skipping' adolescent girls will participate in the following randomized within-subject crossover-design breakfast study. The participants will randomly complete the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals(i.e., 350 kcal; 15% of the meal as protein, 65% CHO, & 20% fat); and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% of the meal as protein, 40% CHO, & 20% fat). On the 7th day of each pattern, the participants will report to the MU-Brain Imaging Center in the morning to complete the respective 10-h testing day. The participants will begin the testing day by either skipping breakfast or consuming their respective breakfast meal. Blood samples and assessments of perceived appetite, pleasure/reward, and cognitive function will be collected/completed at specific times throughout the day. A standardized lunch will also be provided. Prior to dinner, a brain scan will be completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. Following the fMRI, the participants will be provided with an ad libitum dinner buffet to consume of the facility. They will also be given evening snacks to consume ad libitum, at home throughout the remainder of the day. There is a 7-day washout period between each breakfast pattern. Primary outcomes include morning, mid-day, afternoon, and evening appetite, satiety, pleasure/reward, hormonal responses (plasma glucose, insulin, ghrelin, and PYY concentrations), brain activation patterns, evening energy intake, and daily energy intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakfast Skipping | Experimental | 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. |
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| Normal Protein Breakfast Meals | Experimental | 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. |
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| Protein-rich Breakfast Meals | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breakfast Skipping | Behavioral | Participants will continue to skip breakfast each morning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption | 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. | 5 weeks |
| Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) | The 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). | 5 weeks |
| Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Energy Intake | Energy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured. | 5 weeks |
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Inclusion Criteria:
The participants must meet the following inclusion criteria:
Exclusion Criteria:
The participants will be excluded from participation in the study if they meet the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather J Leidy, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23446906 | Derived | Leidy HJ, Ortinau LC, Douglas SM, Hoertel HA. Beneficial effects of a higher-protein breakfast on the appetitive, hormonal, and neural signals controlling energy intake regulation in overweight/obese, "breakfast-skipping," late-adolescent girls. Am J Clin Nutr. 2013 Apr;97(4):677-88. doi: 10.3945/ajcn.112.053116. Epub 2013 Feb 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Normal Protein Breakfast Meals | Behavioral | Participants will consume normal protein breakfast meals each morning. |
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| Protein-rich Breakfast Meals | Behavioral | Participants will consume protein-rich breakfast meals each morning. |
|
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
| 5 weeks |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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 |
| FG004 | 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. |
| FG005 | 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. |
| Began 1st Intervention Week |
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| Began 2nd Intervention Week |
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| Began 3rd Intervention Week |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption | 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. | Posted | Mean | Standard Error | mm*min | 5 weeks |
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| Primary | Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) | The 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). | Posted | Mean | Standard Error | (pg*min)/ml | 5 weeks |
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| Primary | Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans | 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 | Coordinates were only determined for regions considered significant by analysis using Brain Voyager. | Posted | Number | Talairach Coordinates | 5 weeks |
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| Secondary | Daily Energy Intake | Energy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured. | Posted | Mean | Standard Error | kilocalories | 5 weeks |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breakfast Skipping | 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. | 0 | 22 | 0 | 22 | ||
| EG001 | Normal Protein Breakfast Meals | 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. | 0 | 22 | 0 | 22 | ||
| EG002 | 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. | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Leidy | Purdue University | 765-496-0184 | hleidy@purdue.edu |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| How strong is your desire to eat? |
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| How much food can you eat right now? |
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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.
| OG002 | 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. |
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| OG001 | Activation After Normal-protein Breakfast is > After High | 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. |
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