studie met gezonde vrijwilligers niet van toepassing
Conditions
Interventions
Test product: diabetes specific tube feed new recipe (approximately 250 ml)
Control product: diabetes specific tube feed original recipe (approximately 250
ml)
Reference product: glucose solution (25
to determine the glycemic index of the test product
Sponsors
Nutricia Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 and = 18.5 and
Exclusion criteria
Exclusion criteria: 1. Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any other medical condition that 2. Any use of anticoagulants, systemic steroids, protease inhibitors or antipsychotics and/or any medication known to affect glucose tolerance and/or to influence digestion and absorption of nutrients within 1 week of screening, in opinion of the Investigator 3. Any known disease which influences digestion and absorption of nutrients within 1 week of screening (in the opinion of the Investigator) 4. Allergy to soy and/or any other known relevant food allergy or intolerance in opinion of the Investigator 5. Adherence to a strict vegan diet 6. Adherence to a weight loss program 7. Picky/fussy eater (being very selective about what to eat) or eating disorder 8. Known pregnancy and/or lactation 9. Current smoking or stopped smoking for 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months) 11. Drug or medicine abuse in opinion of the Investigator 12. Any known bleeding disorder 13. Active participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before study visit 1, in the opinion of the Investigator 14. Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the Investigator 15. Investigator*s uncertainty about the willingness or ability of the subject to comply with the protocol requirements 16. Employees of Nutricia Research and/or family members or relatives of employees
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose iAUC0-120 [mmol/L*min] and the blood glucose iCmax [mmol/L] (test product versus control product) | — |
Secondary
| Measure | Time frame |
|---|---|
| - GI = blood glucose iAUC0-120 [mmol/L] of test product / mean blood glucose iAUC0-120 [mmol/L] of reference product - Glycemic Load (GL) = GI * available carbohydrate/given amount of carbohydrate | — |
Countries
Netherlands
Outcome results
None listed