Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ONS, glucose.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Primary outcome measures
- Glycaemic Index (GI) of ONS [Time frame: Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07479251 · GCOS-015-CEN