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

NCT07479251 | Not Yet Recruiting

• 1 other identifier: GCOS-015-CEN
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS)

OTHER

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; Other: glucose

Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)

OTHER

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; Other: glucose

Interventions

ONS DIETARY_SUPPLEMENT

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

Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS); Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)

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.

Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS); Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead
• Oxford Brookes University: collaborator

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Sangeetha Thondre, Dr

CONTACT

+44 1865 534136; pthondre@brookes.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03