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

APR Applied Pharma Research SA0 个研究点目标入组 30 人开始时间: 2019年3月19日最近更新: 2023年5月29日

适应症

试验速览

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)

•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.

•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

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