Health TrialsbyHealthPanel

cGMP: Metabolism and Appetite Modulation

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Nova de Lisboa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men or women

Adults (age ≥ 18 years)

Body Mass Index (BMI) between 18.5-25.0 kg/m2

Filling informed consent

Disqualifiers

Clinically significant illness

Have changed frequency, duration, or intensity of physical activity in the last month

Taking protein supplements

Pregnant or breastfeeding

Trial design

Design model

Crossover

Treatments tested in this trial

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

    Dietary supplement

    cGMP-AAs alone (20 g of protein equivalent)

  • 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

  • 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

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Meal AExperimental treatment 1 intervention
Group B: Meal BExperimental treatment 1 intervention
Group C: Meal CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
180 minutes
2

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.

Time frame
180 minutes
3

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.

Time frame
180 minutes
4

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.

Time frame
180 minutes

Secondary outcomes

1

Changes in glucose

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.

Time frame
180 minutes
2

Changes in insulin

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.

Time frame
180 minutes
3

Changes in C-peptide

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.

Time frame
180 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Nova de Lisboa

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: