Amino AcidsNCT06628024
Determination of the Postprandial Amino Acid Uptake Kinetics of Yoghurt Vs Milk.
A study testing Milk and Yoghurt in people with Amino Acids and Milk, run by Nutricia Research at 1 site in Netherlands.
Trial summary
Subjects will visit the study site twice in a fasting state. Subjects asked to consume one of the two study products in a random order. Subjects will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acids, Milk, Yoghurt
- What is being tested?
- Milk and Yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Nov 2024to 31 Jan 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 and ≤ 40 years at time of ICF signature
- 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 known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in 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 medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production and/or gastrointestinal motility or function and/or protein metabolism (for example: antibiotics, anticonvulsants, prokinetics, antacids, opioid analgesics, anticoagulants, corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or insulin).
- Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome.
- Any ongoing cancer and/or cancer treatment (except for non metastasizing cancer e.g basal cell carcinoma).
- Known anaemia or low haemoglobin or low iron status
Show all 15Show fewer
- Any known bleeding disorder.
- Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/ intermittent fasting/ high protein diet (\>1.6 g/kg body weight/day) or a weight loss program.
- Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance.
- Known pregnancy and/or lactation.
- Current smoking / vaping/ use of e-cigarette or stopped smoking for \<
- 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/ e-cigarettes/cigars/pipes per week on average in the last month prior to screening). 12. 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). 13. Drug or medicine abuse in opinion of the investigator. 14. Use of any nutritional supplements or additional protein supplements or nutritional support within 4 weeks prior to screening. 15. Known difficulties with placement of and/or blood drawings from a cannula. 16. Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit
- Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the investigator.
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- Employees of Danone Research and of the investigational site and/or their family members or relatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Postprandial Amino Acid Uptake Kinetics of Yoghurt Vs Milk: a Randomized Controlled Clinical Trial in Health Individuals - a Bioavailability Study
Subjects will visit the study site twice in a fasting state. Subjects asked to consume one of the two study products in a random order. Subjects will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Blood samples will be taken at baseline and then at various timepoints after product intake. A follow up call will take place 7 days after the final study visit.
- Conditions
- Amino Acids, Milk, Yoghurt
- Being tested
- Milk, Yoghurt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkOther
Milk
YoghurtOther
Yoghurt
| Study group | Role | What they receive |
|---|---|---|
| Yoghurt | Experimental | Yoghurt test product (Commercially available) Receives: Other: Yoghurt |
| Milk | Other | Commercially available product Receives: Other: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amino acid concentrations after ingestion of product A vs B in 16 healthy adults
To compare the relative amount (iAUC) total amino acids (TAA) appearing in the blood for the 4-hour period after the ingestion of product A versus B.
Measured: For 4 hours after product intake
Secondary outcomes (1)
Maximum concentration (Cmax) after ingestion of product A vs B in 16 healthy adults
To compare the maximum concentration (Cmax) and time to peak (Tmax) for total amino acids appearing in the blood for the 4-hour period after the ingestion of product A versus B in 16 healthy adults.
Measured: For 4 hours after product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start19 Nov 2024
- Primary completion23 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino AcidsStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628024
- Sponsor's protocol ID
- Nutraferm; 24REX0075382
- Status last verified
- Jan 2025
- First submitted
- 1 Oct 2024
- Last updated
- 24 Feb 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Postprandial Amino Acid Uptake Kinetics of Yoghurt Vs Milk: a Randomized Controlled Clinical Trial in Health Individuals - a Bioavailability Study
- ClinicalTrials.gov ID
- NCT06628024
- Acronym / sponsor ID
- Nutraferm; 24REX0075382
- Conditions
- Amino Acids, Milk, Yoghurt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 4 Oct 2024 (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.
Subjects will visit the study site twice in a fasting state. Subjects asked to consume one of the two study products in a random order. Subjects will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Blood samples will be taken at baseline and then at various timepoints after product intake. A follow up call will take place 7 days after the final study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoghurt | Experimental | Other: YoghurtYoghurt test product (Commercially available) |
| Milk | Other | Other: MilkCommercially available product |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ≥ 18 and ≤ 40 years at time of ICF signature
- 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 (15 listed)
- Any known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in 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 medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production and/or gastrointestinal motility or function and/or protein metabolism (for example: antibiotics, anticonvulsants, prokinetics, antacids, opioid analgesics, anticoagulants, corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or insulin).
- Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome.
- Any ongoing cancer and/or cancer treatment (except for non metastasizing cancer e.g basal cell carcinoma).
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 |
|---|---|---|
| MilkMilk | Other | Milk |
| YoghurtYoghurt | Other | Yoghurt |
Primary outcome
Total amino acid concentrations after ingestion of product A vs B in 16 healthy adults
Time frame: For 4 hours after product intake
To compare the relative amount (iAUC) total amino acids (TAA) appearing in the blood for the 4-hour period after the ingestion of product A versus B.
1 secondary outcome
Maximum concentration (Cmax) after ingestion of product A vs B in 16 healthy adults
Time frame: For 4 hours after product intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk and Yoghurt in people with Amino Acids and Milk, 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 15 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: finished, as of the sponsor's last update on 24 Feb 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amino acid concentrations after ingestion of product A vs B in 16 healthy adults (time frame: For 4 hours after product intake). 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 24 Feb 2025.