Postprandial Amino Acid Concentrations in Healthy AdultsNCT06153225
Amino Acid Concentrations in Serum After Intake of Different Protein Sources
A study testing Protein products in people with Postprandial Amino Acid Concentrations in Healthy Adults, run by Nutricia Research at 1 site in Netherlands.
Trial summary
This study assesses the amino acid concentrations in subject serum after intake of different types of proteins. The study is divided in two consecutive sub-studies. Subjects will be asked to ingest a specific protein blend each visit in a randomized order, after which blood will be drawn on 14 different time points. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Amino Acid Concentrations in Healthy Adults
- What is being tested?
- Protein products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Apr 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 70 years
- Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
- Written informed consent
- Willingness and ability to comply with the protocol
- Judged by the Investigator to be in good health
Who cannot join
- Any gastrointestinal (GI) disease or surgery that may interfere with GI function and/or protein metabolism, including but not limited to phenylketonuria, pancreatitis, short bowel syndrome, celiac disease, Crohn's disease, in the opinion of the Investigator
- Known renal or hepatic diseases that may interfere with protein metabolism, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease, in the opinion of the Investigator
- Use of systemic antibiotics, anticonvulsants, prokinetics, antacids, medication influencing gastric acid production, systemic anticoagulants, systemic corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants or insulin within the past 3 weeks prior to screening
- Allergy to soy, pea and/or cow's milk protein
- Adherence to a weight loss program
- Current eating disorder, e.g. anorexia nervosa or bulimia
Show all 16Show fewer
- Known pregnancy and/or lactation
- Current smoking or stopped smoking for < 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month prior to screening)
- Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months prior to screening)
- Drug or medicine abuse in opinion of the investigator
- Any known bleeding disorder
- Known difficulties with placement of and/or blood drawings from a cannula
- Active participation in any other study with investigational or marketed products concomitantly or within 4 weeks prior to screening
- Major medical or major surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Employees of Nutricia Research and/or their family members or relatives
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
NCRU
Utrecht, 3584 CT
Monique Visser
About this study
Official title: Amino Acid Concentrations in Serum After Intake of Plant Based Protein Sources
This study assesses the amino acid concentrations in subject serum after intake of different types of proteins. The study is divided in two consecutive sub-studies. Subjects will be asked to ingest a specific protein blend each visit in a randomized order, after which blood will be drawn on 14 different time points. At least 48 hours will be kept between each visit, and the subjects receive a follow up call within 4-14 days after visit 4.
- Being tested
- Protein products
- Keywords
- Postprandial, Healthy individuals, Amino acid, Bioavailability, Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein productsDietary supplement
In total 4 protein products will be tested containing a single or mixture of plant and dairy protein sources in a randomized order
| Study group | Role | What they receive |
|---|---|---|
| Sub study 1 | Experimental | All subjects will receive 4 study products (300ml each) on 4 different visits in a randomized order. In total in both arms combined, 7 products will be tested. Receives: Dietary Supplement: Protein products |
| Sub study 2 | Experimental | All subjects will receive 4 study products (300ml each) on 4 different visits a randomized order. In total in both arms combined, 7 products will be tested. Receives: Dietary Supplement: Protein products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino Acid concentration in blood
Relative content of amino acids in dietary protein and relative amount of amino acids appearing in the blood for the 4 hour period after the ingestion of different products [μmol]
Measured: 240 minutes after dietary protein ingestion
Secondary outcomes (1)
Individual Amino Acid concentration in blood
Postprandial serum concentrations of individual amino acids [μmol/L]
Measured: 240 minutes after dietary protein ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start15 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Amino Acid Concentrations in Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153225
- Sponsor's protocol ID
- SBB22R&40716
- Status last verified
- Nov 2023
- First submitted
- 7 Apr 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Concentrations in Serum After Intake of Plant Based Protein Sources
- ClinicalTrials.gov ID
- NCT06153225
- Acronym / sponsor ID
- SBB22R&40716
- Keywords
- Postprandial, Healthy individuals, Amino acid, Bioavailability, Protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 1 Dec 2023 (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.
This study assesses the amino acid concentrations in subject serum after intake of different types of proteins. The study is divided in two consecutive sub-studies. Subjects will be asked to ingest a specific protein blend each visit in a randomized order, after which blood will be drawn on 14 different time points. At least 48 hours will be kept between each visit, and the subjects receive a follow up call within 4-14 days after visit 4.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub study 1 | Experimental | Dietary Supplement: Protein productsAll subjects will receive 4 study products (300ml each) on 4 different visits in a randomized order. In total in both arms combined, 7 products will be tested. |
| Sub study 2 | Experimental | Dietary Supplement: Protein productsAll subjects will receive 4 study products (300ml each) on 4 different visits a randomized order. In total in both arms combined, 7 products will be tested. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 and ≤ 70 years
- Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
- Written informed consent
- Willingness and ability to comply with the protocol
- Judged by the Investigator to be in good health
Key exclusion criteria (16 listed)
- Any gastrointestinal (GI) disease or surgery that may interfere with GI function and/or protein metabolism, including but not limited to phenylketonuria, pancreatitis, short bowel syndrome, celiac disease, Crohn's disease, in the opinion of the Investigator
- Known renal or hepatic diseases that may interfere with protein metabolism, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease, in the opinion of the Investigator
- Use of systemic antibiotics, anticonvulsants, prokinetics, antacids, medication influencing gastric acid production, systemic anticoagulants, systemic corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants or insulin within the past 3 weeks prior to screening
- Allergy to soy, pea and/or cow's milk protein
- Adherence to a weight loss program
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 |
|---|---|---|
| Protein productsIn total 4 protein products will be tested containing a single or mixture of plant and dairy protein sources in a randomized order | Dietary supplement | Sub study 1, Sub study 2 |
Primary outcome
Amino Acid concentration in blood
Time frame: 240 minutes after dietary protein ingestion
Relative content of amino acids in dietary protein and relative amount of amino acids appearing in the blood for the 4 hour period after the ingestion of different products [μmol]
1 secondary outcome
Individual Amino Acid concentration in blood
Time frame: 240 minutes after dietary protein ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Postprandial Amino Acid Concentrations in Healthy Adults
Recruiting
Effects of P24 on Postprandial Aminoacidemia
Postprandial Amino Acid Concentrations in Healthy Adults
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein products in people with Postprandial Amino Acid Concentrations in Healthy Adults, run by Nutricia Research at 1 site in Netherlands.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danone Nutricia Research (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino Acid concentration in blood (time frame: 240 minutes after dietary protein ingestion). 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 11 Dec 2023.