Measurement of the glycaemic index (GI) of Diben 2 KCAL Drink and Renalive HIGH PROTEIN in healthy subjects

Not Applicable

• Conditions: Healthy subjects

• Registration Number: DRKS00032832
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Healthy subjects who give informed consent to participate in the study and fulfill the eligibility criteria according to ISO26642 and study protocol

Exclusion Criteria

- Aged < 18 or > 60 years;
- Pregnant or lactating;
- Body mass index (BMI) < 18.5 kg/m2 or > 30 kg/m2;
- Known history of diabetes mellitus or fasting blood glucose value > 6.1 mmol/l or the use of anti-hyperglycaemic drugsor 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 influencedigestion 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 glucosemetabolism and body fat distribution);
- Suspicion of alcohol abuse (defined as an average daily intake of more than 6 units of alcohol per day, e.g. more than 2 pints of beer per day or equivalent amount of alcohol in other beverages) or drug abuse;
- Participants who are unable to comply with experimental procedures or do not follow GI testing safety guidelines or are not able to tolerate fasting condition for at least 10 hours

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. The baseline value taken as a mean of these two values. The product will be consumed immediately after this within 15 minutes and further bloodsamples will be taken at 15, 30, 45, 60, 90 and 120 minutes after starting to eat/drink.