- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05971563
Amino Acid Kinetics of GMP-AA in Healthy Human Volunteers
Amino Acid Kinetics of GMP-AA vs. Phenylalanine-free Amino Acids Compared With Natural Protein in Healthy Adults Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
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). Protein substitute is composed of non-essential and essential amino acids which replace natural protein in the diet in order to enable normal growth and suppression of blood Phe levels.
It is suggested that CGMP has a slower absorption than usual protein substitute based on amino acids only (amino acids-AA). This compositional change may enhance protein utilization leading to improved blood Phe control. In PKU, any protein substitute that has its absorption closer to the normal 'physiological state' should be advantageous but pure CGMP is lacking in several essential and conditionally essential amino acids (e.g. tyrosine, leucine, tryptophan, histidine). To ensure that CGMP is safe for PKU, it is supplemented with deficient AA (CGMP-AA). Evidence from 'normal' nutritional research suggests that adding AA to natural protein (similar to CGMP-AA), worsens rather than improves efficiency of protein absorption. It is essential to ascertain if CGMP-AA enhances, worsens or has the same absorption when compared with traditional AA substitutes, particularly when prescribing CGMP-AA for children and maternal PKU. The investigators aim to perform a three-part, randomized, controlled, trial in healthy adult volunteers comparing absorption of CGMP-AA (study product 1) vs. AA (study product 2) vs. normal protein (casein) (study product 3). After overnight fasting, healthy volunteers will consume a standard dose of each of the study products. Over the course of 4 hours, plasma AA will be monitored 8 times and this will provide greater insight into the kinetic absorption of CGMP-AA in PKU. The investigators hope these results will add to existing safety and efficacy data about using CGMP-AA in PKU.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Midlands
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Birmingham, West Midlands, United Kingdom, B15 2TT
- University Hospitals Birmingham NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Casein
|
Natural protein
|
Active Comparator: Glycomacropeptide
|
Glycomacropeptide based protein substitute for Phenylketonuria
|
Active Comparator: L- amino acids
|
Synthetic amino acids based protein substitute for Phenylketonuria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total EAA concentrations
Time Frame: 240 minutes for each protein
|
To compare the total EAA concentrations after oral ingestion of one dose of three different protein supplements: cGMP-AA vs. AA only vs. casein.
|
240 minutes for each protein
|
Mean CMAX
Time Frame: 240 minutes for each protein
|
Mean CMAX within 240 minutes of ingestion of each of the 3 proteins
|
240 minutes for each protein
|
AUC of EAA's
Time Frame: 240 minutes for each protein
|
AUC of EAA's within 240 minutes of ingestion of each of the 3 proteins
|
240 minutes for each protein
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Curve characteristics (Cmax)
Time Frame: 240 minutes for each protein
|
Curve characteristics (Cmax) of the following quantities:
|
240 minutes for each protein
|
Curve characteristics (AUC)
Time Frame: 240 minutes for each protein
|
Curve characteristics (AUC) of the following quantities:
|
240 minutes for each protein
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Amino Acid Metabolism, Inborn Errors
- Phenylketonurias
- Molecular Mechanisms of Pharmacological Action
- Chelating Agents
- Sequestering Agents
- Caseins
Other Study ID Numbers
- 281421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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