Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals
| Registry | NCT06215534, acronym GLIN#3 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, other |
| Enrollment | 12 (Actual) |
| Sponsor | Nutricia Research (Industry) |
| Conditions | Glycemic Response |
| Interventions | first reference product series 1, second reference product seies 1, third reference product series 1, first concept product series 1, second concept product series 1, third concept product series 1, 4th concept product seris 1, 5th concept product series 1, 6th concept product series 1, 1st reference product series 2, 2nd reference product series 2, 3rd reference product series 2, 1st concept product series 2, 2nd concept product series 2, 3rd concept product series 2, 4th concept product series 2, 5th concept product series 2, 6th concept product series 2 (Dietary supplement) |
| Dates | start 2024-02-07, primary completion 2024-06-12, completion 2024-06-12, first posted 2024-01-22, last updated 2024-08-01 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Glycemic Response All trials of first reference product series 1 All trials of second reference product seies 1
This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| arm 1 | Other | Dietary Supplement: first reference product series 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 2 | Other | Dietary Supplement: second reference product seies 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 3 | Other | Dietary Supplement: third reference product series 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 4 | Other | Dietary Supplement: first concept product series 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 5 | Other | Dietary Supplement: second concept product series 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 6 | Other | Dietary Supplement: third concept product series 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 7 | Other | Dietary Supplement: 4th concept product seris 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 8 | Other | Dietary Supplement: 5th concept product series 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 9 | Other | Dietary Supplement: 6th concept product series 1 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 10 | Other | Dietary Supplement: 1st reference product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 11 | Other | Dietary Supplement: 2nd reference product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 12 | Other | Dietary Supplement: 3rd reference product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 13 | Other | Dietary Supplement: 1st concept product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 14 | Other | Dietary Supplement: 2nd concept product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 15 | Other | Dietary Supplement: 3rd concept product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 16 | Other | Dietary Supplement: 4th concept product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 17 | Other | Dietary Supplement: 5th concept product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
| arm 18 | Other | Dietary Supplement: 6th concept product series 2 | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: * Age ≥ 18 and ≤ 65 years * Body mass index (BMI) between 18.5 and 27 kg/m² Exclusion Criteria: * Baseline fasting Glucose ≥6.1 at screening visit * Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results. * Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results. * Major trauma or surgical event within 3 months of screening. * Known intolerance, sensitivity or allergy to test products. * Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.). * History of cancer in the prior two years, except for non-melanoma skin cancer.
| Facility | City | Country | Status |
|---|---|---|---|
| Inquis Clinical research | Toronto | Canada |