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Nutricia has a range of nutritionally complete tube feeds on the market including some specific for diabetes patients. A new product is currently under development. The aim of the present study is to assess whether the postprandial glucose response of the new product is equivalent to the postprandial glucose response of an original product. In addition, the Glycaemic Index (GI) and Glycaemic Load (GL) of the adapted product will be determined. The study will have a crossover design with healthy volunteers taking one serving of both products in a randomized order. To determine GI and GL of the adapted product subjects will also receive a reference product. Subjects will visit the study site six times: one screening visit, three study visits to measure the glucose response to the reference product and two study visits to measure the glucose response to the test and control product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New product - Original product | Other | All subjects will receive first product A and then product B. In addition, the reference product will also be received (three times a glucose solution during the trial). |
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| Original product - New product | Other | All subjects will receive first product B and then product A. In addition, the reference product will also be received (three times a glucose solution during the trial). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral intake of one serving of the original and new product | Dietary Supplement | 1) Intervention type: Dietary Supplement Intervention name: (visits 1, 3 and 5) Reference product Intervention description: Glucose solution 2) Intervention type: Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: : One serving new product 3) Intervention type: : Dietary Supplement Intervention name: (visit 2 or 4) Diabetes specific tube feed Intervention description: One serving original product |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose - Product A versus Product B | Blood glucose iAUC0-120 [mmol/L*min] [mmol/L] | 120 minutes |
| Blood glucose - Product A versus Product B | Blood glucose iCmax [mmol/L] [mmol/L] | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| GI new product | GI = blood glucose iAUC0-120 [mmol/L] of new product / mean blood glucose iAUC0-120 [mmol/L] of reference product | 120 minutes |
| GL new product | GL = GI * available carbohydrate/given amount of carbohydrate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monique Visser, PhD | Nutricia Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCRU | Utrecht | 3582CT | Netherlands |
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Single blind
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| 120 minutes |