Healthy
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTcGMP-AAs alone (20 g of protein equivalent)
cGMP-AAs alone (20 g of protein equivalent)
DIETARY_SUPPLEMENTcGMP-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 + 160 g of unpeeled apple
DIETARY_SUPPLEMENTcGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil
cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil
Sponsors
Universidade Nova de Lisboa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men or women * Adults (age ≥ 18 years) * Body Mass Index (BMI) between 18.5-25.0 kg/m2 * Filling informed consent
Exclusion criteria
* Clinically significant illness * Have changed frequency, duration, or intensity of physical activity in the last month * Taking protein supplements * Pregnant or breastfeeding * Smoking and drug use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP) | 180 minutes | 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. |
| Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1) | 180 minutes | 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. |
| Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK) | 180 minutes | 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. |
| Changes in the iAUC (pmol/L*min) for peptide YY (PYY) | 180 minutes | 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. |
| Changes in the iAUC (mmol/L*min) for total amino acids | 180 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in insulin | 180 minutes | 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. |
| Changes in C-peptide | 180 minutes | 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. |
| Changes in glucose | 180 minutes | 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. |
Countries
Portugal
Outcome results
None listed