Bioequivalence of a diabetes specific tube feed with a new carbohydrate source
- Conditions
- studie met gezonde vrijwilligersniet van toepassing10018424
- Registration Number
- NL-OMON51846
- Lead Sponsor
- utricia Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
1. Age >= 18 and <= 65 years
2. Body Mass Index (BMI) >= 18.5 and <= 27.0 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health
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 < 1 month prior to screening (except
for incidental smoking of <= 3 cigarettes/cigars/pipes per week on average in
the last month)
10. Average alcohol use of > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method