healthy volunteers
Conditions
Interventions
Duration of intervention: 2 weeks
- Product A: New hypoallergenic infant formula in one serving
- Product B: Current hypoallergenic infant formula in one serving
Sponsors
Nutricia Research
Eligibility
Inclusion criteria
Inclusion criteria: - Age ≥ 18 and ≤ 40 years - Non-Asian race* - Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2 - Willingness and ability to comply with the protocol - Willingness to use a method of birth control during participation in the study (women only) - Written informed consent - Judged by the investigator to be in good health * Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
Exclusion criteria
Exclusion criteria: - Any medical condition that interferes significantly with digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, diaphraghma hernia or diaphraghma surgery, gastric ulcer, gastritis, (gastro)enteritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery) - Known renal or hepatic failure or known thyroid dysfunction - Any known food allergy and/or food intolerance - Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment - Serum 25(OH)D of < 50 nmol/l - Haemoglobin in men <7.5 mmol/l and in women <7.0 mmol/l - Use of any medication within 3 weeks of screening except for oral contraceptive and incidental use of paracetamol and/or nonsteroidal anti-inflammatory drugs (e.g. ibuprofen and aspirin) - - Known hypersensitivity to esomeprazole, and fructose-intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency - Use of nutritional supplements (other than vitamin D) within two weeks of Visit 1 - Unsuccessful placement of a cannula for taking blood samples at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is the serum P AUC(0-360) [mmol/L*min] (product A compared to product B). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome parameters in this study are comparisons of product A and B on: - Serum P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], Tmax [min] - Serum Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC(0-360) [mmol/L*min], iAUC(0-360) [mmol/L*min], Tmax [min] - Serum creatinine [µmol/L] (product A - B), Cmax, AUC0-360 [µmol/L*min], Tmax [min] - Serum iPTH [pmol/L] (product A - B), Cmax, AUC0-360 [pmol/L*min], Tmax [min] - Serum AP [U/L] (product A - B), Cmax, AUC0-360 [U/L*min], Tmax [min] - Urinary P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC(0-370) [mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min] - Urinary Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC(0-370) [mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min] - Urinary creatinine [mmol/L] (product A - B), Cmax, AUC(0-370) [mmol/L*min] and Tmax [min] | — |
Contacts
Public ContactMonique Visser
Nutricia Research PO Box 80141
Outcome results
None listed