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

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

Treatments tested in this trial

  • ONS
  • glucose

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Fresenius Kabi

Lead sponsor

Oxford Brookes University

Collaborator