cGMP: Metabolism and Appetite Modulation

January 20, 2025 updated by: Universidade Nova de Lisboa

Metabolic Effects of cGMP: From Amino Acid Absorption Kinetics to Appetite Modulation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1169-056
        • NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa,
        • Contact:
        • Contact:
        • Principal Investigator:
          • Júlio César Rocha, PhD
        • Principal Investigator:
          • Ana Faria, PhD
        • Principal Investigator:
          • Anita MacDonald, PhD
        • Sub-Investigator:
          • Conceição Calhau, PhD
        • Sub-Investigator:
          • Catarina Rodrigues, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meal A
Meal A - CGMP-AAs alone
Dietary supplement: cGMP-AAs alone (20 g of protein equivalent)
cGMP-AAs alone (20 g of protein equivalent)
Experimental: Meal B
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
cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled apple
Experimental: Meal C
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
cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the iAUC (mmol/L*min) for total amino acids
Time Frame: 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.
180 minutes
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
Time Frame: 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.
180 minutes
Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK)
Time Frame: 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.
180 minutes
Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
Time Frame: 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.
180 minutes
Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP)
Time Frame: 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.
180 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glucose
Time Frame: 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.
180 minutes
Changes in insulin
Time Frame: 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.
180 minutes
Changes in C-peptide
Time Frame: 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.
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 3, 2025

Primary Completion (Estimated)

March 28, 2025

Study Completion (Estimated)

April 24, 2025

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • cGMP: Metabolism and Appetite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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