Status:
COMPLETED
Amino Acid Kinetics of GMP-AA in Healthy Human Volunteers
Lead Sponsor:
Birmingham Women's and Children's NHS Foundation Trust
Conditions:
Phenylketonurias
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Children with phenylketonuria (PKU) are treated with a special diet supplemented with a synthetic protein based on amino acids. These have a poor taste and are inefficiently used by the body. A differ...
Detailed Description
In the USA, casein glycomacropeptide (CGMP), a low phenylalanine (Phe) 64-amino acid peptide derived from cheese whey, is widely promoted as a low Phe protein substitute in phenylketonuria (PKU). Prot...
Eligibility Criteria
Inclusion
- Male and female healthy subjects without PKU;
- 18 to 50 years of age;
- Female subjects with a negative urine pregnancy test prior to entry into the study and who are practicing an adequate method of birth control during the study;
- Good general health status proven by medical history and clinical laboratory values within normal limits or considered not clinically significant by the investigator;
- Non-smokers or not current smokers;
- Body mass index (BMI) between 18 and 30 kg/m2 and weight (kg)
- No existence of disorders or any comorbidity.
- Willing to follow the study protocol and to take the study products;
- Able to understand study procedures and sign informed consent.
Exclusion
- History of alcohol or drugs abuse;
- Smokers;
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the study;
- Received an investigational drug or device within 30 days (or 5 half-lives, whichever is longer) of dosing;
- Existence of any disorder, food allergy or comorbidity (clinically significant including gastrointestinal, renal, pulmonary, hepatic, cardiovascular and endocrine disorders) - to be decided by investigator from medical history;
- Current illness or infection that could interfere with the study;
- Use of laxatives;
- Use of antibiotics in the last 3 months;
- Use of medication that could influence protein metabolism (like growth hormone, anabolic steroids, hormone replacement) - to be judged by the investigator;
- Participation in any clinical trial in the last 3 months;
- Blood donation within the past 3 months;
- On a medically prescribed diet;
- Unable to follow the study protocol or provide consent;
- Unable to take or tolerate one of the study products.
Key Trial Info
Start Date :
October 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05971563
Start Date
October 18 2022
End Date
August 31 2023
Last Update
March 4 2025
Active Locations (1)
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1
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TT