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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONS

Dietary Supplement

Each administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates.

Glucose

Other

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sangeetha Thondre, Dr

CONTACT

[email protected]

+44 1865 534136

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Collaborators

Oxford Brookes University

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 18, 2026
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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