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Measurement of the glycaemic index (GI) of an enteral nutrition formulation in healthy subjects

Measurement of the glycaemic index (GI) of an enteral nutrition formulation in healthy subjects - GCOS-010-CEN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029379
Enrollment
10
Registered
2022-08-18
Start date
2022-08-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Group 1: Diben POWDER (Vanille), once p.o., volume containing 25 g or 50g available carbohydrates (depending on results of nutrient analysis) Group 2: Glucose, 25 g oder 50 g p.o. on 3 separate days.

Sponsors

Fresenius Kabi Deutschland GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy subjects who give informed consent to participate in the study and fulfill the eligibility criteria according to ISO 26642

Exclusion criteria

Exclusion criteria: - Aged 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

Design outcomes

Primary

MeasureTime frame
Glycaemic index (GI). 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.

Countries

United Kingdom

Contacts

Public ContactIsabel Butler

Centre Manager, Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences and Social Work, Faculty of Health & Life Sciences, Oxford Brookes University

ibutler@brookes.ac.uk+44 (0) 1865-483297

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026