NCT07243730

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Nov 2025Sep 2026

Study Start

First participant enrolled

November 7, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

December 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 17, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

Amino acidsYogurtMilk

Outcome Measures

Primary Outcomes (1)

  • Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B

    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

    5 hours

  • Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B

    2 hours

  • Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B

    5 hours

  • Maximum Concentration (Cmax) of Total Amino Acids and Essential Amino Acids in Blood After Ingestion of Product A or Product B

    5 hours

Study Arms (2)

Yogurt first, Milk second

ACTIVE COMPARATOR

All subjects will receive 2 study products on separate visits in a randomized order.

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.

Other: Full fat yogurt (fermented)Other: Generic full fat pasteurized milk (non-fermented)

Interventions

Test

Milk first, Yogurt secondYogurt first, Milk second

Control

Milk first, Yogurt secondYogurt first, Milk second

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EB Medical Research

Almere Stad, Netherlands

RECRUITING

Central Study Contacts

Danone Global Research and Innovation Center

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: A randomized controlled clinical study in healthy participants
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

November 7, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations