cGMP: Metabolism and Appetite Modulation

NCT06794515 | Not Yet Recruiting

• 1 other identifier: cGMP: Metabolism and Appetite
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Changes in the iAUC (mmol/L*min) for total amino acids

  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.

  180 minutes

• Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)

  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.

  180 minutes

• Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK)

  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.

  180 minutes

• Changes in the iAUC (pmol/L*min) for peptide YY (PYY)

  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.

  180 minutes

• Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP)

  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.

  180 minutes

Secondary Outcomes (3)

• Changes in glucose

  180 minutes

• Changes in insulin

  180 minutes

• Changes in C-peptide

  180 minutes

Study Arms (3)

Meal A

EXPERIMENTAL

Meal A - CGMP-AAs alone

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

Meal B

EXPERIMENTAL

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

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

Meal C

EXPERIMENTAL

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

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

Interventions

cGMP-AAs alone (20 g of protein equivalent) DIETARY_SUPPLEMENT

cGMP-AAs alone (20 g of protein equivalent)

Meal A

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 + 160 g of unpeeled apple

Meal B

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

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

Meal C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead

Study Sites (1)

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

Lisbon, 1169-056, Portugal

Location

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: February 3, 2025
• Primary Completion: March 28, 2025
• Study Completion: April 24, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)