Healthy ParticipantsNCT07479251
Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants
A study testing ONS and glucose in people with Healthy Participants, run by Fresenius Kabi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- ONS and glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- ONS, glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSDietary supplement
Each administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates.
glucoseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: ONS; Other: glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oxford Brookes University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479251
- Sponsor's protocol ID
- GCOS-015-CEN
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants
- ClinicalTrials.gov ID
- NCT07479251
- Acronym / sponsor ID
- GCOS-015-CEN
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Collaborators
- Oxford Brookes University
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS) | Other | Dietary Supplement: ONS, Other: glucoseParticipants 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). |
| Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose) | Other | Dietary Supplement: ONS, Other: glucoseParticipants 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONSEach administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates. | Dietary supplement | Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS), Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose) |
| glucoseThe 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 A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS), Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ONS and glucose in people with Healthy Participants, run by Fresenius Kabi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sangeetha Thondre, Dr (+44 1865 534136, pthondre@brookes.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic Index (GI) of ONS (time frame: Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.