Glycemic Response Clinical Trial
— GLIN#3Official title:
Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals
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.
| Status | Recruiting |
| Enrollment | 12 |
| Est. completion date | June 30, 2024 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Inquis Clinical research | Toronto |
| Lead Sponsor | Collaborator |
|---|---|
| Nutricia Research |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The glycemic index of nutritional products | 6 months | ||
| Secondary | 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references | 6 months | ||
| Secondary | 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references | 6 months |
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