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CompletedNCT06628024Updated Feb 24, 2025

Determination of the Postprandial Amino Acid Uptake Kinetics of Yoghurt Vs Milk.

An interventional study of Milk and Yoghurt in Amino Acids, Milk and Yoghurt, sponsored by Nutricia Research. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Nutricia Research · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Amino Acids
  • Milk
  • Yoghurt
03

In context

Lead sponsor

Nutricia Research is the lead sponsor of 48 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age ≥ 18 and ≤ 40 years at time of ICF signature
  2. Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
  3. Written informed consent
  4. Willingness and ability to comply with the protocol
  5. Judged by the Investigator to be in good health

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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).
  4. Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome.
  5. Any ongoing cancer and/or cancer treatment (except for non metastasizing cancer e.g basal cell carcinoma).
  6. Known anaemia or low haemoglobin or low iron status
  7. Any known bleeding disorder.
  8. 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.
  9. Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance.
  10. Known pregnancy and/or lactation.
  11. 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Yoghurt

    Yoghurt test product (Commercially available)

    Other: Yoghurt

  • Other
    Milk

    Commercially available product

    Other: Milk

Interventions

  • OtherMilk

    Milk

  • OtherYoghurt

    Yoghurt

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: For 4 hours after product intake

Other outcomes

  1. Time to peak of essential amino acids after ingestion of product A vs B in 16 healthy adults

    To compare time to peak (Tmax), for essential amino acids (EAA) of product A versus product B.

    Time frame: For 4 hours after product intake

  2. Relative amount of essential amino acid concentrations after consumption of product A vs. product B in 16 healthy adults.

    To compare the relative amount (iAUC) of essential amino acids (EAAs) appearing in the blood for the 4-hour period after the ingestion of product A versus product B.

    Time frame: For 4 hours after product intake

  3. Maximum concentration (Cmax) of essential amino acids (EAAs) after product A vs. product B in 16 healthy adults.

    To compare maximum concentration (Cmax) of essential amino acids (EAAs) appearing in the blood for the 4-hour period after the ingestion of product A versus product B.

    Time frame: For 4 hours after product intake

  4. Time to peak of leucine product A vs. product B in 16 healthy adults

    To compare time to peak (Tmax) for leucine of product A versus product B.

    Time frame: For 4 hours after product intake

  5. Relative amount of leucine after product A vs. product B in 16 healthy adults.

    To compare the relative amount (iAUC) of leucine appearing in the blood for the 4-hour period after the ingestion of product A versus product B.

    Time frame: For 4 hours after product intake

  6. Maximum concentration of leucine after product A vs. product B in 16 healthy adults

    To compare maximum concentration (Cmax) of leucine appearing in the blood for the 4-hour period after the ingestion of product A versus product B.

    Time frame: For 4 hours after product intake

07

Study locations

1 site
  • EB FlevoResearch
    Almere, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06628024
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Oct 4, 2024
Start date
Nov 19, 2024
Primary completion
Dec 23, 2024
Completion
Jan 31, 2025
Last update
Feb 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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