Healthy volunteers Healthy
Conditions
Interventions
milk protein concentrate products with addition of different amino acids in different amounts.
Sponsors
Danone Global research & Innovation center
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age = 18 and = 40 years at the time of Informed Consent Form signature. Body Mass Index (BMI) = 18.5 and = 29.9 kg/m2. Signed informed consent. Willingness and ability to comply with the protocol. Judged by the Investigator to be in good health.
Exclusion criteria
Exclusion criteria: Any known surgery or ongoing medical condition that significantly interferes with protein absorption and digestion: Gastrectomy (partial or total), Bariatric surgeries (e.g., Roux-en-Y gastric bypass, sleeve gastrectomy), Pancreatic resection, Small bowel resection, Ileal resection, Celiac disease, Crohn’s disease, Ulcerative colitis, Short bowel syndrome, Tropical sprue, Zollinger-Ellison Syndrome, Liver Disease (e.g., Cirrhosis, Chronic liver disease), Intestinal lymphangiectasia, Radiation enteritis, Obstruction of bile ducts (e.g., gallstones, strictures, tumors). Known GI or renal or hepatic, or neurological diseases/conditions that may interfere with protein metabolism in the opinion of the investigator, including but not limited to Hirschsprung’s disease, acute hepatitis, chronic kidney disease, Phenylketonuria (PKU), Homocystinuria, Parkinson’s disease, Multiple sclerosis, Myasthenia gravis. Any known medical condition that can affect GI motility or passage of food through intestine, including but not limited to: Achalasia, GERD, Gastroparesis. Any known ongoing acute or chronic infection in the GI tract/ urinary tract including, but not limited to: inflammatory bowel disease, gastroesophageal reflux disease, gastric ulcer, chronic gastritis, nephritis, cystinuria. Any cardiovascular disease (including, but not limited to hypertension, arrhythmia, or atrial fibrillation) or respiratory disease (including, but not limited to asthma, COPD) which is not controlled with the use of medication/therapy. Use of systemic medication within the 3 weeks prior to visit 1 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 - clindamycin, cephalosporins, fluoroquinolones, ampicillin, amoxicillin, tetracyclines, beta-lactams, fluoroquinolones, macrolides, oxazolidinones, and aminoglycosides) PPIs, H2-blockers, opiates, antidiarrheal drugs (e.g. loperamide), anticoagulants (e.g. Warfarin), anticonvulsants (e.g. Phenytoin), Benzodiazepines (e.g. Diazepam), Diuretics (e.g. Furosemide), Non-selective B blockers (e.g. Propranolol), Ca++ channel blocker (e.g. Verapamil), Levodopa, Octreotide)). Occasional use of regular over the counter medication such as Rennie Deflatine and painkillers is allowed. Known or suspected Diabetes Mellitus type I or type II, pre-diabetes, insulin resistance, metabolic syndrome, or risk of hypoglycemia. Any ongoing cancer and/or cancer treatment (except for non-melanoma skin cancer or carcinoma in situ). Known anaemia and/or known bleeding disorder. A blood donation within 56 days (8 weeks) for men; or 122 days (4 months) for women; prior to the screening. 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. Known allergy or intolerance of, or unwillingness to consume, any ingredients as listed in the study product composition, e.g milk proteins, lactose or collagen derived from beef. . Known pregnancy and/or lactation. Current smoking / vaping / use of e-cigarette / or stopped smoking for < 1 month prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess net incremental area under the curve for amino acid concentrations from 0 to 300 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of the amino acid composition of the study product on maximum concentrations and time to maximum concentrations of amino acids in the blood. | — |
Countries
Netherlands
Contacts
Public ContactETHC Smeets
Danone Global research & Innovation center
Outcome results
None listed