Amino acids, Yoghurt, Milk
Conditions
Interventions
yogurt-cultured, ultra-filtered milk product 
generic full fat pasteurized milk
Sponsors
Danone Global Research and Innovation Center
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 and = 40 years at the time of ICF signature2. Body Mass Index (BMI) = 18.5 and = 29.9 kg/m23. Signed informed consent4. Willingness and ability to comply with the protocol5. Judged by the Investigator to be in good health
Exclusion criteria
Exclusion criteria: 1. Any known surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and/or gastrointestinal (GI) function (e.g. phenylketonuria, pancreatitis, short bowel syndrome, inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, gastric ulcer, chronic gastritis, gastrointestinal cancer, oesophageal and/or gastric surgery), in the 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 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 opinion of the investigator. 15. Current eating disorder, 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 Research and of the investigational site and/or their family members or relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the amount of essential amino acids (EAAs) appearing in the serum circulation (incremental area under the curve, iAUC) during the early-phase postprandial period (0-120 min) following ingestion of a yogurt-cultured ultra-filtered milk product versus generic pasteurized milk. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare, between yogurt-cultured ultra-filtered milk product and generic pasteurized milk, during the 5-hour period following ingestion:the amount of leucine, total amino acids (TAAs), branch-chain amino acids (BCAAs), and non-essential amino acids (NEAAs) appearing in the serum circulation during early-phase postprandial period (iAUC0-120).the maximum concentrations (Cmax) of serum leucine, EAA, TAA, BCAA, and NEAA concentrations.The iAUC half time (T1/2 iAUC) of serum leucine, EAAs, TAAs, BCAAs, and NEAAs. | — |
Countries
Netherlands
Contacts
Public ContactB.C.E.M. Wolfs
Danone Global Research and Innovation Center
Outcome results
None listed