Bioavailability of phosphorus after oral intake of two hypoallergenic infant formulas in healthy adult volunteers with a neutral stomach pH

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

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 (only women)
- Written informed consent
- Judged by the investigator to be in good health;*(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

- Any medical condition that interferes significantly with digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease. diaphragmatic hernia or diaphragmatic 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
- 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 containing 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome in this study is the serum P AUC0-360 [mmol/L*min] (product<br /><br>A versus product B). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome parameters in this study are comparisons of product A and<br /><br>B on:<br /><br>- Serum P [mmol/L] Cmin [mmol/L] and Tmin [min]<br /><br>- Urinary P [mmol/L] Cmax [mmol/L], AUC70-370 [mmol/Lmin] and Tmax [min]<br /><br>- Serum Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC0-360 [mmol/Lmin],<br /><br>iAUC0-360 [mmol/Lmin] and Tmax [min]<br /><br>- Urinary Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC70-370 [mmol/Lmin],<br /><br>iAUC70-370 [mmol/L*min] and Tmax [min]</p><br>