cGMP: Metabolism and Appetite Modulation

Condition(s) studied

Investigational drug(s) / intervention(s)

cGMP-AAs alone (20 g of protein equivalent): cGMP-AAs alone (20 g of protein equivalent)

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 + 160 g of unpeeled apple

cGMP-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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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 (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.

Trial sites (1)

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