Glin3: Assessment of the Glycemic Responses to Nutritional Products
Not Applicable
Completed
- Conditions
- Glycemic Response
- Interventions
- Dietary Supplement: second reference product seies 1Dietary Supplement: first reference product series 1Dietary Supplement: second concept product series 1Dietary Supplement: third concept product series 1Dietary Supplement: third reference product series 1Dietary Supplement: first concept product series 1Dietary Supplement: 5th concept product series 1Dietary Supplement: 2nd reference product series 2Dietary Supplement: 1st concept product series 2Dietary Supplement: 2nd concept product series 2Dietary Supplement: 4th concept product seris 1Dietary Supplement: 4th concept product series 2Dietary Supplement: 6th concept product series 1Dietary Supplement: 1st reference product series 2Dietary Supplement: 3rd reference product series 2Dietary Supplement: 3rd concept product series 2Dietary Supplement: 6th concept product series 2Dietary Supplement: 5th concept product series 2
- Registration Number
- NCT06215534
- Lead Sponsor
- Nutricia Research
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description arm 2 second reference product seies 1 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 1 first reference product series 1 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 5 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 third concept product series 1 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 3 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 first concept product series 1 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 8 5th concept product series 1 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 11 2nd reference product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 13 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 2nd concept product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 7 4th concept product seris 1 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 16 4th concept product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 9 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 1st reference product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 12 3rd reference product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 15 3rd concept product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 18 6th concept product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. arm 17 5th concept product series 2 All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
- Primary Outcome Measures
Name Time Method The glycemic index of nutritional products 6 months
- Secondary Outcome Measures
Name Time Method 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references 6 months 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references 6 months
Trial Locations
- Locations (1)
Inquis Clinical research
🇨🇦Toronto, Canada