Not applicable (healthy volunteers)
Conditions
Interventions
3 high-protein, yoghurt-cultured dairy products that vary in the amount of EAAs they contain. 
Sponsors
Danone Global R&I Center
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 and = 40 years at the time of 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
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 determine during the 5-hour postprandial period following ingestion of three high-protein, yogurt-cultured, dairy products the maximum concentration (Cmax) of essential amino acids in the blood circulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine during the 5-hour postprandial period following ingestion of three high-protein, yogurt-cultured, dairy products: The Cmax of serum or plasma total amino acids (TAAs), non-essential amino acids (NEAAs), and branch-chain amino acids (BCAAs) . The amount of leucine, EAA, TAA, NEAA, and BCAA concentrations appearing in the serum/plasma (iAUC) during the full postprandial period (iAUC0-300), early phase postprandial period (iAUC0-120), and late phase postprandial period (iAUC120-300). The time at which maximum serum/plasma leucine, EAAs, TAAs, NEAAs, and BCAAs concentrations occur (Tmax). Correlation coefficients between postprandial Cmax and iAUC of serum/ plasma leucine concentrations and amount of whey ingested (absolute amount [g] and amount corrected for body weight [g/kg]). Appetite-related measurements (satiety, fullness, hunger, and prospective food consumption), and their Composite Satiety Score (CSS). | — |
Countries
Netherlands
Contacts
Public ContactE. Gerrits
Danone Global R&I Center
Outcome results
None listed