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Phenylketonuria is an inborn error of phenylalanine metabolism. Although the phenylalanine-restricted diet is recognized as the mainstay of therapy, little is known about the impact of protein substitutes on the metabolism of patients with phenylketonuria.
Therefore, the aim of this project is to study the impact of acute ingestion of casein glycomacropeptide supplemented with amino acids (cCGMP-AAs) alone or in combination with two different meals on amino acid absorption kinetics, glycaemic and insulinemic response, and on acute markers of appetite control.
The main findings of this project will bring new insights into the dietary management of these patients, which may lead to improvements in protein substitutes formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal A | Experimental | Meal A - CGMP-AAs alone |
|
| Meal B | Experimental | Meal B - CGMP-AAs in combination with carbohydrates (including fibre) |
|
| Meal C | Experimental | Meal C - CGMP-AAs in combination with carbohydrates and fat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cGMP-AAs alone (20 g of protein equivalent) | Dietary Supplement | cGMP-AAs alone (20 g of protein equivalent) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the iAUC (mmol/L*min) for total amino acids | Total amino acids will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (mmol/L*min) for amino acids will be calculated based on the concentration curve following consumption of the test meal. | 180 minutes |
| Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1) | GLP-1 will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L*min) for GLP-1 will be calculated based on the concentration curve following consumption of the test meal. | 180 minutes |
| Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK) | CCK will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L*min) for CCK will be calculated based on the concentration curve following consumption of the test meal. | 180 minutes |
| Changes in the iAUC (pmol/L*min) for peptide YY (PYY) | PYY will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L*min) for PYY will be calculated based on the concentration curve following consumption of the test meal. | 180 minutes |
| Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP) | GIP will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L*min) for GIP will be calculated based on the concentration curve following consumption of the test meal. | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glucose | Glucose will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (mmol/L*min) for glucose will be calculated based on the concentration curve following consumption of the test meal. | 180 minutes |
| Changes in insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa, | Lisbon | 1169-056 | Portugal |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled apple | Dietary Supplement | cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled apple |
|
| cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil | Dietary Supplement | cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil |
|
Insulin will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (mmol/L*min) for insulin will be calculated based on the concentration curve following consumption of the test meal. |
| 180 minutes |
| Changes in C-peptide | C-peptide will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (mmol/L*min) for C-peptide will be calculated based on the concentration curve following consumption of the test meal. | 180 minutes |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |