Assessment of the Glycemic Responses to Nutritional Products (v2.0)

Study Overview
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Brief Summary
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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.

Official Title
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Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals (v2.0)

Conditions
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Glycemic Response

Intervention / Treatment
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* Dietary Supplement: First Reference product
* Dietary Supplement: Second Reference product
* Dietary Supplement: Third Reference product
* Dietary Supplement: First Concept product
* Dietary Supplement: Second Concept product
* Dietary Supplement: Third Concept product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 65 years Body mass index (BMI) between 18.5 and 27 kg/m² Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1 (Reference)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. | Dietary Supplement: First Reference product<br>* Dextrose (containing 25 grams of carbohydrates)<br>|
| Other: Arm 2 (Reference)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. | Dietary Supplement: Second Reference product<br>* Dextrose (containing 25 grams of carbohydrates)<br>|
| Other: Arm 3 (Reference)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. | Dietary Supplement: Third Reference product<br>* Dextrose (containing 25 grams of carbohydrates)<br>|
| Other: Arm 4 (Concept)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. | Dietary Supplement: First Concept product<br>* Infant Formula (containing 25 grams of carbohydrates)<br>|
| Other: Arm 5 (Concept)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. | Dietary Supplement: Second Concept product<br>* Infant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates)<br>|
| Other: Arm 6 (Concept)<br>All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. | Dietary Supplement: Third Concept product<br>* Infant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The glycemic index of nutritional products |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references |  | 3 months | 
| The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic index, Glycemic response, Nutritional products, Healthy individuals