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

NCT ID: NCT06628024

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-19
• Study Completion Date: 2025-01-31

Brief 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.

Conditions

Amino Acids; Milk; Yoghurt

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Yoghurt

Yoghurt test product (Commercially available)

Group Type: EXPERIMENTAL

Yoghurt

Intervention Type: OTHER

Yoghurt

Milk

Commercially available product

Group Type: OTHER

Milk

Intervention Type: OTHER

Milk

Interventions

Milk

Milk

Intervention Type: OTHER

Yoghurt

Yoghurt

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

EB FlevoResearch

Almere Stad, , Netherlands

Countries

Netherlands

Other Identifiers

Nutraferm; 24REX0075382

Identifier Type: -

Identifier Source: org_study_id