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

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.

Study Overview

• Status: Completed
• Conditions: Amino Acids; Milk; Yoghurt
• Intervention / Treatment: Other: Yoghurt; Other: Milk

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Almere, Netherlands
    • EB FlevoResearch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoghurt; Yoghurt test product (Commercially available)	Other: Yoghurt; Yoghurt
Other: Milk; Commercially available product	Other: Milk; Milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For 4 hours after product intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For 4 hours after product intake

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For 4 hours after product intake
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.	For 4 hours after product intake
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.	For 4 hours after product intake
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.	For 4 hours after product intake
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.	For 4 hours after product intake
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.	For 4 hours after product intake

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Actual): December 23, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Nutraferm; 24REX0075382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No