Measurement of the glycaemic index (GI) of an enteral nutrition formulation in healthy subjects
- Conditions
- Healthy subjects
- Registration Number
- DRKS00029379
- Lead Sponsor
- Fresenius Kabi Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
Healthy subjects who give informed consent to participate in the study and fulfill the eligibility criteria according to ISO 26642
- Aged < 18 or > 60 years;
- Pregnant or lactating;
- Body mass index (BMI) > 30 kg/m2;
- Known history of diabetes mellitus or fasting blood glucose value > 6.1 mmol/l or the use of anti-hyperglycaemic drugs or insulin to treat diabetes and related conditions;
- Any known food allergy or intolerance;
- Medical condition(s) or medication(s) known to affect glucose regulation, tolerance or appetite and/or which influence digestion and absorption of nutrients (excluding oral contraceptives);
- Major medical or surgical event requiring hospitalization within the preceding 3 months;
- Use of steroids, protease inhibitors, amphetamines or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution);
- Participants who are unable to comply with experimental procedures or do not follow GI testing safety guidelines
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycaemic index (GI). <br>Blood samples will be taken at -5 min and 0 min before consumption of the product and the baseline value taken as a mean of these two values. The product will be consumed immediately after this within 15 minutes and further blood samples will be taken at 15, 30, 45, 60, 90 and 120 minutes after starting to eat/drink. Additional blood samples will be taken at 150 and 180 minutes for a 3-hour test.
- Secondary Outcome Measures
Name Time Method