Bioavailability of Amino AcidsNutraFerm2NCT07243730
Amino Acids in the Blood After Eating Yoghurt and Milk Proteins
A study testing Full fat yogurt (fermented) and Generic full fat pasteurized milk (non-fermented) in people with Bioavailability of Amino Acids, run by Nutricia Research at 1 site in Netherlands.
Trial summary
Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order. Participants 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
- Bioavailability of Amino Acids
- What is being tested?
- Full fat yogurt (fermented) and Generic full fat pasteurized milk (non-fermented)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Nov 2025to 22 Dec 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 the time of (Informed Consent Form) ICF signature
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed informed consent
- Willingness and ability to comply with the protocol
- Judged by the Investigator to be in good health.
Who cannot join
- Any known surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and/or gastrointestinal (GI) function in the opinion of the investigator, including but not limited to the following: phenylketonuria, pancreatitis, short bowel syndrome, inflammatory bowel disease, celiac disease, gastroesophageal reflux disease, gastric ulcer, chronic gastritis, gastrointestinal cancer, esophageal and/or gastric surgery, and any cardiovascular disease (such as hypertension, arrhythmia, or atrial fibrillation) which is not controlled with the use of medication/therapy.
- Known renal or hepatic diseases that may interfere with protein metabolism in the opinion of the investigator, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease.
- 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 (e.g., antibiotics, anticonvulsants, prokinetics, antacids or gastric acid inhibitors, 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-melanoma skin cancer or carcinoma in situ).
- Known anaemia.
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- A blood donation within 56 days (8 weeks) for men; or 122 days (4 months) for women; prior to the screening.
- 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).
- 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 the opinion of the investigator.
- Current eating disorders, e.g. anorexia nervosa, bulimia nervosa, binge eating disorder.
- Use of protein, amino acid, or creatine supplements within 4 weeks prior to screening.
- Known difficulties with placement of and/or blood drawings from a cannula.
- Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit 1.
- 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 participant to comply with the protocol requirements.
- Employees of Danone Global Research \& Innovation Center 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 Early Postprandial Essential Amino Acid Bioavailability of Yogurt vs Milk A Randomized Controlled Clinical Trial in Healthy Volunteers - A Bioavailability Study -
Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order. Participants will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Two blood samples will be taken at baseline and then at 14 timepoints after product intake. A follow up call will take place 7 (-3/+7) days after the final study visit.
- Conditions
- Bioavailability of Amino Acids
- Being tested
- Full fat yogurt (fermented), Generic full fat pasteurized milk (non-fermented)
- Keywords
- Amino acids, Yogurt, Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full fat yogurt (fermented)Other
Test
Generic full fat pasteurized milk (non-fermented)Other
Control
| Study group | Role | What they receive |
|---|---|---|
| Yogurt first, Milk second | Active comparator | All subjects will receive 2 study products on separate visits in a randomized order. Receives: Other: Full fat yogurt (fermented); Other: Generic full fat pasteurized milk (non-fermented) |
| Milk first, Yogurt second | Active comparator | All subjects will receive 2 study products on separate visits in a randomized order. Receives: Other: Full fat yogurt (fermented); Other: Generic full fat pasteurized milk (non-fermented) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B
Measured: 2 hours
Secondary outcomes (4)
Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Essential Amino Acids in Blood After Ingestion of Product A or Product B
Measured: 5 hours
Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B
Measured: 2 hours
Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B
Measured: 5 hours
Maximum Concentration (Cmax) of Total Amino Acids and Essential Amino Acids in Blood After Ingestion of Product A or Product B
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start7 Nov 2025
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of 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
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized controlled clinical study in healthy participants
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT07243730
- Sponsor's protocol ID
- 25REX0091083
- Acronym
- NutraFerm2
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Early Postprandial Essential Amino Acid Bioavailability of Yogurt vs Milk A Randomized Controlled Clinical Trial in Healthy Volunteers - A Bioavailability Study -
- ClinicalTrials.gov ID
- NCT07243730
- Acronym / sponsor ID
- NutraFerm2 / 25REX0091083
- Conditions
- Bioavailability of Amino Acids
- Keywords
- Amino acids, Yogurt, Milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 24 Nov 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.
Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order. Participants will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Two blood samples will be taken at baseline and then at 14 timepoints after product intake. A follow up call will take place 7 (-3/+7) days after the final study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled clinical study in healthy participants
| Arm | Type | Receives |
|---|---|---|
| Yogurt first, Milk second | Active comparator | Other: Full fat yogurt (fermented), Other: Generic full fat pasteurized milk (non-fermented)All subjects will receive 2 study products on separate visits in a randomized order. |
| Milk first, Yogurt second | Active comparator | Other: Full fat yogurt (fermented), Other: Generic full fat pasteurized milk (non-fermented)All subjects will receive 2 study products on separate visits in a randomized order. |
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 the time of (Informed Consent Form) ICF signature
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed informed consent
- Willingness and ability to comply with the protocol
- Judged by the Investigator to be in good health.
Key exclusion criteria (21 listed)
- Any known surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and/or gastrointestinal (GI) function in the opinion of the investigator, including but not limited to the following: phenylketonuria, pancreatitis, short bowel syndrome, inflammatory bowel disease, celiac disease, gastroesophageal reflux disease, gastric ulcer, chronic gastritis, gastrointestinal cancer, esophageal and/or gastric surgery, and any cardiovascular disease (such as hypertension, arrhythmia, or atrial fibrillation) which is not controlled with the use of medication/therapy.
- Known renal or hepatic diseases that may interfere with protein metabolism in the opinion of the investigator, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease.
- 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 (e.g., antibiotics, anticonvulsants, prokinetics, antacids or gastric acid inhibitors, 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-melanoma skin cancer or carcinoma in situ).
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 |
|---|---|---|
| Full fat yogurt (fermented)Test | Other | Milk first, Yogurt second, Yogurt first, Milk second |
| Generic full fat pasteurized milk (non-fermented)Control | Other | Milk first, Yogurt second, Yogurt first, Milk second |
Primary outcome
Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B
Time frame: 2 hours
4 secondary outcomes
Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Essential Amino Acids in Blood After Ingestion of Product A or Product B
Time frame: 5 hours
Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B
Time frame: 2 hours
Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B
Time frame: 5 hours
Maximum Concentration (Cmax) of Total Amino Acids and Essential Amino Acids in Blood After Ingestion of Product A or Product B
Time frame: 5 hours
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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Indispensable Amino Acids Bioavailability in Children With Environmental Enteropathy Dysfunction (IAA-EED)
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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 Full fat yogurt (fermented) and Generic full fat pasteurized milk (non-fermented) in people with Bioavailability of Amino Acids, 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 21 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 28 Oct 2026. 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?
Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B (time frame: 2 hours). 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 28 Oct 2026.