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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07479251
Enrollment
30
Registered
2026-03-18
Start date
2026-03-01
Completion date
2026-12-01
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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

DIETARY_SUPPLEMENTONS

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

OTHERglucose

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

Fresenius Kabi
Lead SponsorINDUSTRY
Oxford Brookes University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Glycaemic Index (GI) of ONSBlood 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.

Contacts

CONTACTSangeetha Thondre, Dr
pthondre@brookes.ac.uk+44 1865 534136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026