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

March 19, 2026 updated by: Fresenius Kabi

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS)
Participants will receive the test product and the control product alternately. They will be randomly assigned to one of the two treatment sequence groups with 15 participants in each group. The randomization will be stratified by race/ethnicity (Chinese, Caucasian).
Dietary supplement: ONS
Each administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates.
Other: glucose
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.
Other: Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)
Participants will receive the test product and the control product alternately. They will be randomly assigned to one of the two treatment sequence groups with 15 participants in each group. The randomization will be stratified by race/ethnicity (Chinese, Caucasian).
Dietary supplement: ONS
Each administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates.
Other: glucose
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic Index (GI) of ONS
Time Frame: 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.
Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Collaborators

Oxford Brookes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCOS-015-CEN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Participants

Clinical Trials on ONS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe