Healthy Participants
Conditions
Brief summary
This clinical trial evaluates the postprandial glycaemic response to an Oral Nutritional Supplement (ONS), a Food for Special Medical Purposes (FSMP), in healthy adults. The study uses a crossover design comparing the ONS to the reference product glucose. Each participant will consume both test and reference products on three separate occasions each, overall on six test days.
Interventions
Each administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates.
The test product will be compared with the reference product glucose (glucose monohydrate dissolved in 250 ml water). Each administration of the reference product will represent 25 g of glycaemic carbohydrates.
Sponsors
Study design
Eligibility
Inclusion criteria
* Aged ≥18 and ≤60 years, adult healthy Caucasian or Chinese participants * Stable body weight within the Body Mass Index between 18.5 kg/m2 and 27.9 kg/m2 (inclusive) * Glycated hemoglobin \< 6%/\< 42 mmol/mol
Exclusion criteria
* Pregnant or lactating, * Body fat percentage exceeding 30%, * Known history of metabolic diseases or diabetes mellitus, * Major medical or surgical event requiring hospitalization within the preceding 3 months * Medical condition(s) or medication(s) or herbal effects known to affect glucose regulation, tolerance or appetite and/or which influence digestion and absorption of nutrients (excluding oral contraceptives), * Use of steroids, protease inhibitors, amphetamines or antipsychotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic Index (GI) of ONS | Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes. | Three GIs for each repeated test of the ONS (based on capillary blood glucose) and their average GI (mean value) will be calculated as per ISO 26642. |