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

Not Applicable

Completed

• Conditions: Phenylketonuria; Nutritional, Metabolic, Endocrine; Classical phenylketonuria

• Registration Number: ISRCTN11016729
• Lead Sponsor: APR Applied Pharma Research SA

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32498426/ results (added 08/06/2020) 2021 Results article in https://doi.org/10.3390/nu13093189 (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2019-04-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rate of absorption will be measured using peak plasma concentration (Cmax) of essential AAs (EAAs) after oral intake. <br>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<br><br>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.