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| Name | Class |
|---|---|
| American Egg Board | OTHER |
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This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.
Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a ~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at ~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Carb then High Protein Breakfast | Active Comparator | A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat). |
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| High Protein then High Carb Breakfast | Active Comparator | A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High protein breakfast | Other | a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose Level Post-meal (AUC [0-4]) | AUC for 4 hr after breakfast and after lunch | 0-240 and 240-480 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC) | AUC for 4 hr after breakfast and after lunch | 0-240 and 240-480 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-meal Insulin Level (AUC [0-4]) | AUC for 4 hr after breakfast and after lunch | 0-240 and 240-480 |
| Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC ) | AUC for 4 hr after breakfast and after lunch |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25733459 | Derived | Park YM, Heden TD, Liu Y, Nyhoff LM, Thyfault JP, Leidy HJ, Kanaley JA. A high-protein breakfast induces greater insulin and glucose-dependent insulinotropic peptide responses to a subsequent lunch meal in individuals with type 2 diabetes. J Nutr. 2015 Mar;145(3):452-8. doi: 10.3945/jn.114.202549. Epub 2014 Dec 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Carb Then High Protein Breakfast | A high carbohydrate breakfast for 7 days, followed by a 7-day washout, followed a high protein breakfast for 7 days |
| FG001 | High Protein Then High Carb Breakfast | A high protein breakfast for 7 days, followed by a 7-day washout, followed a high carbohydrate breakfast for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Washout (7 Days) |
| |||||||||||||
| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Carb Then High Protein Breakfast | A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days |
| BG001 | High Protein Then High Carb Breakfast |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Plasma Glucose Level Post-meal (AUC [0-4]) | AUC for 4 hr after breakfast and after lunch | Posted | Mean | Standard Error | min*pg/ml | 0-240 and 240-480 |
|
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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 | High Protein Breakfast | a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) high protein breakfast high carbohydrate breakfast |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jill Kanaley | University of Missouri | 573-882-2519 | kanaleyj@missouri.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| High carb breakfast | Other | a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) |
|
| 0-240 and 240-480 |
| NOT COMPLETED |
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| NOT COMPLETED |
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A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC) | AUC for 4 hr after breakfast and after lunch | Posted | Mean | Standard Error | min*pg/ml | 0-240 and 240-480 |
|
|
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| Other Pre-specified | Post-meal Insulin Level (AUC [0-4]) | AUC for 4 hr after breakfast and after lunch | Posted | Mean | Standard Error | min*pg/ml | 0-240 and 240-480 |
|
|
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| Other Pre-specified | Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC ) | AUC for 4 hr after breakfast and after lunch | Posted | Mean | Standard Error | ng/ml x min for 4 h | 0-240 and 240-480 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | High Carbohydrate Breakfast | a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) high protein breakfast high carbohydrate breakfast | 0 | 12 | 0 | 12 |
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| D004700 | Endocrine System Diseases |