HealthyNCT06794515
cGMP: Metabolism and Appetite Modulation
A study testing 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 and cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil in people with Healthy, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 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 and cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Feb 2025to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women
- Adults (age ≥ 18 years)
- Body Mass Index (BMI) between 18.5-25.0 kg/m2
- Filling informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa,
Lisbon, 1169-056
Ana Faria, PhD, 00351218803033, ana.faria@nms.unl.pt
Catarina Rodrigues, MSc, 00351218803033, catarina.rodrigues@nms.unl.pt
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 appleDietary 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 oilDietary supplement
cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil
| Study group | Role | What they receive |
|---|---|---|
| Meal A | Experimental | Meal A - CGMP-AAs alone Receives: Dietary Supplement: cGMP-AAs alone (20 g of protein equivalent) |
| Meal B | Experimental | Meal B - CGMP-AAs in combination with carbohydrates (including fibre) Receives: 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 Receives: Dietary Supplement: cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 minutes
Secondary outcomes (3)
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.
Measured: 180 minutes
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.
Measured: 180 minutes
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.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start3 Feb 2025 (estimated)
- Primary completion28 Mar 2025 (estimated)
- Study completion24 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794515
- Sponsor's protocol ID
- cGMP: Metabolism and Appetite
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of cGMP: From Amino Acid Absorption Kinetics to Appetite Modulation
- ClinicalTrials.gov ID
- NCT06794515
- Acronym / sponsor ID
- cGMP: Metabolism and Appetite
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 3 Feb 2025 (estimated)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meal A | Experimental | Dietary Supplement: cGMP-AAs alone (20 g of protein equivalent)Meal A - CGMP-AAs alone |
| Meal B | Experimental | Dietary Supplement: cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled appleMeal B - CGMP-AAs in combination with carbohydrates (including fibre) |
| Meal C | Experimental | Dietary Supplement: cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oilMeal C - CGMP-AAs in combination with carbohydrates and fat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women
- Adults (age ≥ 18 years)
- Body Mass Index (BMI) between 18.5-25.0 kg/m2
- Filling informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cGMP-AAs alone (20 g of protein equivalent)cGMP-AAs alone (20 g of protein equivalent) | Dietary supplement | Meal A |
| cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled applecGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled apple | Dietary supplement | Meal B |
| cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oilcGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil | Dietary supplement | Meal C |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Changes in glucose
Time frame: 180 minutes
Changes in insulin
Time frame: 180 minutes
Changes in C-peptide
Time frame: 180 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa,
Lisbon, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil in people with Healthy, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the iAUC (mmol/L*min) for total amino acids (time frame: 180 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.