The hypothesis formulation for the primary outcome parameter is: -H0: The effect of using test product (Product A) is equal to the effect of using control product (Product B) with respect to the area under the curve (AUC(0-360))of serum P. -H1:…
ID
Bron
Verkorte titel
Aandoening
healthy volunteers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome parameter in this study is the serum P AUC(0-360) [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 a new hypoallergenic infant formula compared to the bioavailability of phosphorus after oral intake of the current hypoallergenic infant formula.
Doel van het onderzoek
The hypothesis formulation for the primary outcome parameter is:
-H0: The effect of using test product (Product A) is equal to the effect of using control product (Product B) with respect to the area under the curve (AUC(0-360))of serum P.
-H1: The effect of using test product (Product A) is unequal to the effect of using control product (Product B) with respect to the area under the curve (AUC(0-360)) of serum P.
Onderzoeksopzet
V1 (day 1), V2 (day 7)
Onderzoeksproduct en/of interventie
Duration of intervention: 2 weeks
- Product A: New hypoallergenic infant formula in one serving
- Product B: Current hypoallergenic infant formula in 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
- 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.
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, 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.
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 | NL6680 |
| NTR-old | NTR6850 |
| Ander register | Protocolnummer Nutricia Research : MPR17TA15103 |