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NCT05971563
Amino Acid Kinetics of GMP-AA in Healthy Human Volunteers
NA trial testing Casein in Phenylketonurias in 20 participants. Completed in 31 August 2023.
31 August 2023
Quick facts
| Lead sponsor | Birmingham Women's and Children's NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 18 October 2022 |
| Primary completion | 31 August 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Casein
- L-amino acids
- CGMP-AA
Conditions studied
- Phenylketonurias — all drugs for Phenylketonurias →
Sponsor
Birmingham Women's and Children's NHS Foundation Trust
Who can join
Adults 18 to 50, any sex, with Phenylketonurias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05971563
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Casein
Trials testing the same drug.
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- NCT03547362 — Real-time Amino Acid Profiling · NA · completed
- NCT03319550 — Whey vs Casein to Combat Post-inflammatory Protein and Muscle Waste in Acute Disease · NA · completed
- NCT02082418 — Effects of Alpha-lactalbumin Intake on Metabolic and Cognitive Functions in Elderly · NA · completed
Other recruiting trials for Phenylketonurias
Currently open trials in the same condition.
- NCT06332807 — AAV Gene Therapy Clinical Study in Adult Classic PKU (PHEdom) · Phase 1, PHASE2 · recruiting
- NCT06560736 — Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria · NA · recruiting
- NCT06718842 — Walking Program in Fatty Liver Children With Phenylketonuria · NA · recruiting
- NCT06687733 — Safety and Efficacy Study of NGGT002 in cPKU Adult Subjects · Phase 1, PHASE2 · recruiting
- NCT06061614 — Safety and Efficacy Study of NGGT002 in PKU Adult Subjects · EARLY_PHASE1 · recruiting
Other Birmingham Women's and Children's NHS Foundation Trust trials
Trials by the same sponsor.
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- NCT04854018 — Indo-cyanine Green (ICG) in Paediatric Oncology MIS · Phase 4 · completed
- NCT04751500 — The HYsteroscopic Miscarriage MaNagement Trial: A Pilot RCT Investigating a Novel Management Pathway for RPOC · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05971563 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Birmingham Women's and Children's NHS Foundation Trust
- Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05971563.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing