cGMP: Metabolism and Appetite Modulation

NCT ID: NCT06794515

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2025-04-24

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Meal A

Meal A - CGMP-AAs alone

Group Type EXPERIMENTAL

cGMP-AAs alone (20 g of protein equivalent)

Intervention Type DIETARY_SUPPLEMENT

cGMP-AAs alone (20 g of protein equivalent)

Meal B

Meal B - CGMP-AAs in combination with carbohydrates (including fibre)

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Meal C

Meal C - CGMP-AAs in combination with carbohydrates and fat

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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cGMP-AAs alone (20 g of protein equivalent)

cGMP-AAs alone (20 g of protein equivalent)

Intervention Type 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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men or women
* Adults (age ≥ 18 years)
* Body Mass Index (BMI) between 18.5-25.0 kg/m2
* Filling informed consent

Exclusion Criteria

* Clinically significant illness
* Have changed frequency, duration, or intensity of physical activity in the last month
* Taking protein supplements
* Pregnant or breastfeeding
* Smoking and drug use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Nova de Lisboa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa,

Lisbon, , Portugal

Site Status

Countries

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Portugal

Facility Contacts

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Ana Faria, PhD

Role: primary

00351218803033

Catarina Rodrigues, MSc

Role: backup

00351218803033

Other Identifiers

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cGMP: Metabolism and Appetite

Identifier Type: -

Identifier Source: org_study_id

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