Bioavailability of phosphorus after oral intake of hypoallergenic infant formula with additional phosphate sources in healthy adult volunteers with a neutral stomach pH. - UP

utricia Research0 sites24 target enrollmentStarted: TBDLast updated: April 15, 2024

Conditions

Trial Snapshot

No summary available.

•- 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.

•- 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
•- Unsuccesfull placement of a cannula for taking blood samples at Visit 1

Sponsor

utricia Research