cGMP: Metabolism and Appetite Modulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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, cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Metabolic Effects of cGMP: From Amino Acid Absorption Kinetics to Appetite Modulation
Overview
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.
Interventions
- Dietary supplement cGMP-AAs alone (20 g of protein equivalent)
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
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 + 10 g of olive oil
cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil
Primary outcome measures
- Changes in the iAUC (mmol/L*min) for total amino acids [Time frame: 180 minutes]
- Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1) [Time frame: 180 minutes]
- Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK) [Time frame: 180 minutes]
- Changes in the iAUC (pmol/L*min) for peptide YY (PYY) [Time frame: 180 minutes]
- Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP) [Time frame: 180 minutes]
Secondary outcome measures (3)
- Changes in glucose [Time frame: 180 minutes]
- Changes in insulin [Time frame: 180 minutes]
- Changes in C-peptide [Time frame: 180 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
Portugal · 1 center
- NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa, — Lisbon
Identifiers
NCT: NCT06794515 · cGMP: Metabolism and Appetite