How yogurt versus milk changes blood amino acids

Determination of the Early Postprandial Essential Amino Acid Bioavailability of Yogurt vs Milk A Randomized Controlled Clinical Trial in Healthy Volunteers - A Bioavailability Study -

This test compares how eating a serving of full-fat yogurt versus full-fat milk changes blood amino acid levels in healthy adults aged 18–40.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Nutricia Research (Industry-sponsored)
• Locations: 1 site (Almere Stad)
• Trial ID: NCT07243730 on ClinicalTrials.gov

What this trial studies

Healthy adults attend two clinic visits after an overnight fast and consume one serving of either full-fat fermented yogurt or full-fat pasteurized milk in random order, with intake completed within about ten minutes. Blood is drawn at baseline and at 14 timepoints after intake to map postprandial amino acid concentrations. Each participant serves as their own control through the crossover design, and a follow-up phone call occurs about one week after the final visit. The trial aims to identify bioavailability differences related to fermentation and processing of milk proteins.

Who should consider this trial

Good fit: Ideal participants are healthy adults 18–40 years old with BMI 18.5–29.9 who can fast, tolerate multiple blood draws, and have no major digestive, renal, or liver conditions.

Not a fit: People with gastrointestinal disorders, known renal or hepatic disease, previous relevant GI surgery, uncontrolled cardiovascular disease, or outside the age/BMI ranges are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, results could help refine dietary guidance by showing whether fermented yogurt delivers amino acids differently than pasteurized milk.

How similar studies have performed: Previous human studies have measured postprandial amino acid responses to dairy proteins and reported differences related to fermentation and processing, so the approach is well established.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤ 40 years at the time of (Informed Consent Form) ICF signature
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
3. Signed 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 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.
2. 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.
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 (e.g., antibiotics, anticonvulsants, prokinetics, antacids or gastric acid inhibitors, 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-melanoma skin cancer or carcinoma in situ).
6. Known anaemia.
7. A blood donation within 56 days (8 weeks) for men; or 122 days (4 months) for women; prior to the screening.
8. Any known bleeding disorder.
9. 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.
10. Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance.
11. Known pregnancy and/or lactation.
12. 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).
13. 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).
14. Drug or medicine abuse in the opinion of the investigator.
15. Current eating disorders, e.g. anorexia nervosa, bulimia nervosa, binge eating disorder.
16. Use of protein, amino acid, or creatine supplements within 4 weeks prior to screening.
17. Known difficulties with placement of and/or blood drawings from a cannula.
18. Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit 1.
19. 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.
20. Investigator's uncertainty about the willingness or ability of the participant to comply with the protocol requirements.
21. Employees of Danone Global Research \& Innovation Center and of the investigational site and/or their family members or relatives.

Where this trial is running

Almere Stad

• EB Medical Research — Almere Stad, Netherlands (Recruiting)

Study contacts

• Study coordinator: Danone Global Research and Innovation Center

Conditions Bioavailability of Amino Acids; Amino acids; Yogurt; Milk