None: healthy volunteers
Conditions
Interventions
Duration of intervention: 2 weeks
- Product A: New hypoallergic infant feeding one serving
- Product B: Comparable hypoallergic infant feeding one serving
Sponsors
Nutricia Research
Eligibility
Inclusion criteria
Inclusion criteria: - Age ≥ 18 and ≤ 40 years - Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2 - Non-Asian race* - 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, celiac disease, diaphraghma hernia or diaphraghma surgery, gastric ulcer, gastritis, (gastro)enteritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator - Known renal or hepatic failure or known thyroid dysfunction - Any known food allergy and/or food intolerance for: cow’s milk, lactose, peanuts, nuts, wheat, soy, potato, carrot, onion, tomato, corn, apple and/or orange - Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment - Serum 25(OH)D of < 50 nmol/l at screening - Haemoglobin (Hb) in men <7.5 mmol/l and in women <7.0 mmol/l at screening- Use of any medication within 1 week of Visit 1 except for oral contraceptive, incidental use of paracetamol and/or nonsteroidal anti-inflammatory drugs (e.g. ibuprofen and aspirin) and/or common cold relievers (e.g. nasal sprays containg xylometazoline and sore throat relievers), if medically justified in opinion of the investigator - 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 serum P AUC0-360 [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] Cmin [mmol/L] and Tmin [min] - Urinary P [mmol/L] Cmax [mmol/L], AUC70-370 [mmol/L*min] and Tmax [min] - Serum Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC0-360 [mmol/L*min], iAUC0-360 [mmol/L*min] and Tmax [min] - Urinary Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC70-370 [mmol/L*min], iAUC70-370 [mmol/L*min] and Tmax [min] | — |
Contacts
Public ContactMonique Visser
Nutricia Research PO Box 80141
Outcome results
None listed