cGMP: Metabolism and Appetite Modulation

Not Applicable

Not yet recruiting

• Conditions: Healthy

• Registration Number: NCT06794515
• Lead Sponsor: Universidade Nova de Lisboa

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Study Start: 2025-02-03
• Primary Completion: 2025-03-28
• Study Completion: 2025-04-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in the iAUC (mmol/L*min) for total amino acids	180 minutes	Total amino acids will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (mmol/L\*min) for amino acids will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)	180 minutes	GLP-1 will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for GLP-1 will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK)	180 minutes	CCK will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for CCK will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (pmol/L*min) for peptide YY (PYY)	180 minutes	PYY will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for PYY will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP)	180 minutes	GIP will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for GIP will be calculated based on the concentration curve following consumption of the test meal.

Secondary Outcome Measures

Name	Time	Method
Changes in glucose	180 minutes	Glucose will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (mmol/L\*min) for glucose will be calculated based on the concentration curve following consumption of the test meal.
Changes in insulin	180 minutes	Insulin will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (mmol/L\*min) for insulin will be calculated based on the concentration curve following consumption of the test meal.
Changes in C-peptide	180 minutes	C-peptide will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (mmol/L\*min) for C-peptide will be calculated based on the concentration curve following consumption of the test meal.

Trial Locations

Locations (1)

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa,; 🇵🇹 Lisboa, Portugal