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Amino Acid Kinetics of GMP-AA in Healthy Human Volunteers

NCT05971563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-04

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Casein

Natural protein

DIETARY_SUPPLEMENT

L-amino acids

Synthetic amino acids based protein substitute for Phenylketonuria

DIETARY_SUPPLEMENT

CGMP-AA

Glycomacropeptide based protein substitute for Phenylketonuria

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971563 on ClinicalTrials.gov