Amino Acid Kinetics of GMP-AA in Healthy Human Volunteers

NCT05971563 | Completed

• 1 other identifier: 281421
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 different type of synthetic protein, called glycomacropeptide is being tried in PKU. It tastes better than amino acids but it requires the addition of some extra amino acids which may worsen how well it is absorbed compared with traditional amino acid supplements. We will perform a 3-part trial in healthy adult volunteers to compare amino acids vs glycomacropeptide protein with a 'normal protein' (casein) to examine the absorption properties of these proteins. Volunteers will take one dose of each of the protein sources on 3 different days. Blood and urine samples will be collected examining the rate of absorption of amino acids over 5 hours on each study day.

Conditions

Phenylketonurias

Outcome Measures

Primary Outcomes (3)

• Total EAA concentrations

  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

  Mean CMAX within 240 minutes of ingestion of each of the 3 proteins

  240 minutes for each protein

• AUC of EAA's

  AUC of EAA's within 240 minutes of ingestion of each of the 3 proteins

  240 minutes for each protein

Secondary Outcomes (2)

• Curve characteristics (Cmax)

  240 minutes for each protein

• Curve characteristics (AUC)

  240 minutes for each protein

Study Arms (3)

Casein

ACTIVE COMPARATOR

Dietary Supplement: Casein

Glycomacropeptide

ACTIVE COMPARATOR

Dietary Supplement: CGMP-AA

L- amino acids

ACTIVE COMPARATOR

Dietary Supplement: L-amino acids

Interventions

Casein DIETARY_SUPPLEMENT

Natural protein

Casein

L-amino acids DIETARY_SUPPLEMENT

Synthetic amino acids based protein substitute for Phenylketonuria

L- amino acids

CGMP-AA DIETARY_SUPPLEMENT

Glycomacropeptide based protein substitute for Phenylketonuria

Glycomacropeptide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female healthy subjects without PKU;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Phenylketonurias

Interventions

Caseins

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A three-way, randomized, controlled, open-label, crossover, single-dose clinical trial in healthy adult volunteers.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 2, 2023
• Study Start: October 18, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: March 4, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)