cGMP: Metabolism and Appetite Modulation

New University of Lisbon

Status: Not yet enrolling

Conditions: Healthy

Treatments: Dietary Supplement: cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil; Dietary Supplement: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06794515

cGMP: Metabolism and Appetite

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Meal A

Experimental group

Description:

Meal A - CGMP-AAs alone

Treatment:

Dietary Supplement: cGMP-AAs alone (20 g of protein equivalent)

Meal B

Experimental group

Description:

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

Treatment:

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

Meal C

Experimental group

Description:

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

Treatment:

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