Examining the absorption of three phenylalanine-free amino acid mixtures, one of which was formulated with the Physiomimic modified-release technology, in healthy volunteers

Comparative bioavailability of amino acids after oral intake of three phenylalanine-free amino acid mixtures – one with a modified-release technology – in healthy volunteers: a randomized crossover trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11016729

Enrollment

Registered

2019-03-19

Start date

2017-10-26

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phenylketonuria Nutritional, Metabolic, Endocrine Classical phenylketonuria

Interventions

Test product = a phenylalanine-free amino acid mixture engineered with a modified-release technology (Physiomimic technology), containing 17 AAs, vitamins, minerals, other nutrients and two food addit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-45 years 2. 55-85 kg 3. Body mass index (BMI) = 30 kg/m2 4. Willing to consume medical nutrition products, specifically AA preparations, and to follow the dietary scheme as required by the protocol 5. Good general health status 6. Non-smokers or not current smokers.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation or planned pregnancy 2. History of clinically significant diseases or malfunctions 3. Current illnesses that could interfere with the study 4. Use of any medication that would significantly affect protein synthesis or turnover, upon the decision of the Investigator 5. Clinically significant abnormalities in screening labs 6. Any medical condition deemed to be exclusionary by the Investigator (reasoning needs to be provided) 7. Any current participation in another clinical trial involving investigational or marketed products in the 3 months prior to the inclusion in this clinical trial 8. Blood donation of =250 mL within the past 3 months 9. Vegetarian diet or any food allergy towards any of the ingredients in the study products or to ingredients of snack bars/meals to be administered during the study 10. Abnormal diets or substantial changes in eating habits with the past 4 weeks 11. Positive to HIV test, or Hepatitis B or C tests

Design outcomes

Primary

Measure	Time frame
1. Rate of absorption will be measured using peak plasma concentration (Cmax) of essential AAs (EAAs) after oral intake. 2. Extent of absorption will be measured using the area under the concentration-time curve (AUC) for EAAs during the first 5 hours after the intake Plasma levels of AAs will be evaluated at the following time points: 30 min before the intake, 0, and 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min and 420 min after the intake.	—

Measure

Time frame

1. Rate of absorption will be measured using peak plasma concentration (Cmax) of essential AAs (EAAs) after oral intake. 2. Extent of absorption will be measured using the area under the concentration-time curve (AUC) for EAAs during the first 5 hours after the intake Plasma levels of AAs will be evaluated at the following time points: 30 min before the intake, 0, and 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min and 420 min after the intake.

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Secondary

Measure	Time frame
1. Rate of absorption will be determined using Cmax of Large Neutral AAs (LNAAs), Branched-chain AAs (BCAAs), and total AAs 2. Extent of absorption in the first 5 hours will be determined using AUC0-300min of LNAAs, BCAAs, and total AAs 3. Extent of absorption during 7 hours will be determined using AUC0-420min of EAAs, LNAAs, BCAAs, and total AAs. 4. Time to reach Cmax will be measured using time to peak (tmax) of EAAs, LNAAs, BCAAs, and total AAs 5. Plasma concentrations of EAAs, LNAAs, BCAAs, and total AAs will be measured at the last evaluable time point before the snack meal (C300min) and at the last evaluable time point after the snack meal (C420min) 6. Plasma levels of blood urea nitrogen (BUN) will be measured at baseline (0 min) and at 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min, 150 min, 180 min, 240 min, and 300 min after the intake 7. Plasma levels of insulin will be evaluated at baseline (0 min) and at 15 min, 30 min, 45 min, 60 min, 120 min, 180 min, 240 min, 300 min after the intake 8. Plasma levels of glucose will be evaluated at baseline (0 min) and at 15 min, 30 min, 45 min, 60 min, 120 min, 180 min, 240 min, 300 min after the intake 9. Urine levels of urea will be evaluated at baseline and over a 0- to 150-min and 150- to 300-min period after the intake 10. Safety and tolerability will be determined by performing ECG, measure of vital signs and blood/urine lab test at the last visit (liver and kidney tests, serum proteins and urine parameters will be also evaluated at the end of the 1st, 2nd and 3rd test days), and by recording any adverse event throughout the whole duration of the study Plasma levels of AAs will be evaluated at the following time points: 30 min before the intake, 0, and 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min and 420 min after the intake.	—

Measure

Time frame

1. Rate of absorption will be determined using Cmax of Large Neutral AAs (LNAAs), Branched-chain AAs (BCAAs), and total AAs 2. Extent of absorption in the first 5 hours will be determined using AUC0-300min of LNAAs, BCAAs, and total AAs 3. Extent of absorption during 7 hours will be determined using AUC0-420min of EAAs, LNAAs, BCAAs, and total AAs. 4. Time to reach Cmax will be measured using time to peak (tmax) of EAAs, LNAAs, BCAAs, and total AAs 5. Plasma concentrations of EAAs, LNAAs, BCAAs, and total AAs will be measured at the last evaluable time point before the snack meal (C300min) and at the last evaluable time point after the snack meal (C420min) 6. Plasma levels of blood urea nitrogen (BUN) will be measured at baseline (0 min) and at 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min, 150 min, 180 min, 240 min, and 300 min after the intake 7. Plasma levels of insulin will be evaluated at baseline (0 min) and at 15 min, 30 min, 45 min, 60 min, 120 min, 180 min, 240 min, 300 min after the intake 8. Plasma levels of glucose will be evaluated at baseline (0 min) and at 15 min, 30 min, 45 min, 60 min, 120 min, 180 min, 240 min, 300 min after the intake 9. Urine levels of urea will be evaluated at baseline and over a 0- to 150-min and 150- to 300-min period after the intake 10. Safety and tolerability will be determined by performing ECG, measure of vital signs and blood/urine lab test at the last visit (liver and kidney tests, serum proteins and urine parameters will be also evaluated at the end of the 1st, 2nd and 3rd test days), and by recording any adverse event throughout the whole duration of the study Plasma levels of AAs will be evaluated at the following time points: 30 min before the intake, 0, and 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min and 420 min after the intake.

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Countries

Finland, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026