Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants

ConditionHealthy Participants

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorFresenius Kabi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

ONS
Dietary supplement
Each administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates.
glucose
Other intervention
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS)Other 2 interventions

Group B: Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)Other 2 interventions

Trial outcomes

Primary outcomes

Glycaemic Index (GI) of ONS

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.

Time frame

Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fresenius Kabi

Lead sponsor

Oxford Brookes University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: