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cGMP: Metabolism and Appetite Modulation

NCT06794515 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-27

No results posted yet for this study

Summary

Phenylketonuria is an inborn error of phenylalanine metabolism. Although the phenylalanine-restricted diet is recognized as the mainstay of therapy, little is known about the impact of protein substitutes on the metabolism of patients with phenylketonuria.

Therefore, the aim of this project is to study the impact of acute ingestion of casein glycomacropeptide supplemented with amino acids (cCGMP-AAs) alone or in combination with two different meals on amino acid absorption kinetics, glycaemic and insulinemic response, and on acute markers of appetite control.

The main findings of this project will bring new insights into the dietary management of these patients, which may lead to improvements in protein substitutes formulations.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

cGMP-AAs alone (20 g of protein equivalent)

cGMP-AAs alone (20 g of protein equivalent)

DIETARY_SUPPLEMENT

cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled apple

cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled apple

DIETARY_SUPPLEMENT

cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil

cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil

Sponsors & Collaborators

  • Universidade Nova de Lisboa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2025-03-28
Completion
2025-04-24

Countries

  • Portugal

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 NCT06794515 on ClinicalTrials.gov