The hypothesis formulation for the primary outcome parameter is: - H0: The effect of using product A is unequal to the effect of using product B with respect to serum P AUC0-360 [mmol/L*min] in subjects with elevated gastric pH. - H1: The effect…
ID
Bron
Verkorte titel
Aandoening
None: healthy volunteers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome parameter in this study is serum P AUC0-360 [mmol/L*min] (product A compared to product B).
Achtergrond van het onderzoek
This randomised, double blind, cross-over single-centre, single-dose study is designed to assess the bioavailability of phosphorus after oral intake of two hypoallergenic infant formula in healthy adult volunteers with a neutral stomach pH.
Doel van het onderzoek
The hypothesis formulation for the primary outcome parameter is:
- H0: The effect of using product A is unequal to the effect of using product B with respect to serum P AUC0-360 [mmol/L*min] in subjects with elevated gastric pH.
- H1: The effect of using product A is equal to the effect of using product B with respect to serum P AUC0-360 [mmol/L*min] in subjects with elevated gastric pH.
Onderzoeksopzet
V1 (day 1), V2 (day 7)
Onderzoeksproduct en/of interventie
Duration of intervention: 2 weeks
- Product A: New hypoallergic infant feeding one serving
- Product B: Comparable hypoallergic infant feeding one serving
Publiek
PO Box 80141
Monique Visser
Utrecht 3508 TC
The Netherlands
+31 30 2095 000
Monique.Visser@danone.com
Wetenschappelijk
PO Box 80141
Monique Visser
Utrecht 3508 TC
The Netherlands
+31 30 2095 000
Monique.Visser@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7367 |
| NTR-old | NTR7575 |
| Ander register | Stichting BEBO : MPR18TA20887 |