A1 Refereed original research article in a scientific journal
Amino Acid Plasma Profiles from a Prolonged-Release Protein Substitute for Phenylketonuria: A Randomized, Single-Dose, Four-Way Crossover Trial in Healthy Volunteers
Authors: Mika Scheinin, Anna Barassi, Jouni Junnila, Zsófia Lovró, Giorgio Reiner, Essi Sarkkinen, Anita MacDonald
Publisher: MDPI
Publication year: 2020
Journal: Nutrients
Journal name in source: NUTRIENTS
Journal acronym: NUTRIENTS
Article number: ARTN 1653
Volume: 12
Issue: 6
Number of pages: 16
eISSN: 2072-6643
DOI: https://doi.org/10.3390/nu12061653
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/48961756
Several disorders of amino acid (AA) metabolism are treated with a protein-restricted diet supplemented with specific AA mixtures. Delivery kinetics impacts AA absorption and plasma concentration profiles. We assessed plasma profiles after ingestion of an AA mixture engineered to prolong AA absorption with Physiomimic Technology(TM)(Test) in a randomized, single-dose, four-way crossover trial in healthy volunteers (Trial Registration: ISRCTN11016729). In a two-step hypothesis, the primary endpoints were (i) significant reduction in peak plasma concentrations (C-max) of essential amino acids (EAAs) while (ii) maintaining EAA bioavailability (AUC(0-300 min)) compared to a free AA mixture (Reference). Secondary endpoints included effects on plasma profiles of other AA groups and effects on several metabolic markers. Thirty subjects completed the study. Both co-primary endpoints were met: C(max)for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726,p< 0.0001); overall plasma EAA levels from the two AA mixtures was within the pre-specified bioequivalence range (AUC(0-300min)ratio, 0.890 (95% CI: 0.865, 0.915)). These findings were supported by the results of secondary endpoints. Prolongation of AA absorption was associated with modulation of several metabolic markers. It will be important to understand whether this can improve the long-term management of disorders of AA metabolism.
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