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

Nutricia

Status

Completed

Conditions

Amino Acids

Milk

Yoghurt

Treatments

Other: Yoghurt

Other: Milk

Study type

Interventional

Funder types

Industry

Identifiers

NCT06628024

Nutraferm 24REX0075382;

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.
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.
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).
Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome.
Any ongoing cancer and/or cancer treatment (except for non metastasizing cancer e.g basal cell carcinoma).
Known anaemia or low haemoglobin or low iron status
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). 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.