H0: The effect of product A is equal to the effect of product B with respect to change from baseline after 8 weeks of study product intake in IL-10 production [pg/mL] AND in Foxp3 expressing cells. H1: The effect of product A is unequal to the…
ID
Bron
Verkorte titel
Aandoening
Immune modulatory activity of a pre-probiotic blend in healthy adult volunteers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change from baseline in IL-10 production and/or forkhead box protein 3 (Foxp3) expressing cells after 8 weeks of daily study product intake.
Achtergrond van het onderzoek
Not yet available
Doel van het onderzoek
H0: The effect of product A is equal to the effect of product B with respect to change from baseline after 8 weeks of study product intake in IL-10 production [pg/mL] AND in Foxp3 expressing cells.
H1: The effect of product A is unequal to the effect of product B with respect to change from baseline after 8 weeks of study product intake in IL-10 production [pg/mL] OR in Foxp3 expressing cells.
Onderzoeksopzet
V1 ( Day 1); V2 (Day 14); V3 (Day 56)
Onderzoeksproduct en/of interventie
Duration of intervention: 8 weeks
Intervention group: A pre-probiotic blend and maltodextrose
Control group: maltodextrose
Algemeen / deelnemers
Monique Visser
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31-30-2095000
monique.visser@nutricia.com
Wetenschappers
Monique Visser
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31-30-2095000
monique.visser@nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥ 18 and ≤ 40 years
- Written informed consent
- Willingness and ability to comply with the study protocol
- Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2
- Non-smoking or stopped smoking for at least 3 months prior to Visit 1 (randomisation)
- Regular stool (stool frequency of at least 1 stool in 3 days)
- Judged by the investigator to be in good health
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Any medical condition that interferes with GI function (e.g irritable bowel syndrome, short bowel syndrome, inflammatory bowel disease, gastric ulcer, gastritis (gastro)enteritis)
- Constipation and/or diarrhoea within 1 week prior to Visit 1 (randomisation)
- Any known allergy and/or intolerance (e.g. coeliac disease, gluten intolerance, allergy to one of the ingredients of the study product)
- Any known renal or hepatic failure
- (History of) any immunological disease and/ or immunodeficiency
- (History of) any cancer with the exception of basal cell carcinoma
- Use of prokinetics, laxatives, antidiarrhoeals, corticosteroids, proton-pump inhibitors (or other gastric acid reducers), immunosuppressants or any active allergy treatment within 3 weeks of Visit 1 (randomisation)
- (History of) any chemotherapy or immunotherapy
- Use of antibiotics within 3 months of screening
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6095 |
| NTR-old | NTR6242 |
| Ander register | Stichting BEBO : 15AL89652 |