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This study assesses the glycemic responses to several nutritional products.
During a study visit fasted subjects will consume one serving of the reference product or of the test products. Venous blood samples will be taken at baseline and at several time-points over a 6-hr period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement/First concept Product 1 (containing 50 grams of carbohydrates) | Active Comparator | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized. |
|
| Dietary supplement/First concept Product 2 (containing 50 grams of carbohydrates) | Active Comparator | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized |
|
| Reference product (containing 50 grams of carbohydrates) | Active Comparator | All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First concept product (containing 50 grams of carbohydrates) | Dietary Supplement | Fasted intake of First concept product (randomised) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decline in glucose level after reaching peak (Cmax) | The decline in glucose (mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline (t = -5) blood glucose levels or, in case baseline blood glucose levels are not reached, the lowest observed blood glucose level. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Area Under the Curve (iAUC) for glucose | Incremental Area Under the Curve (iAUC) for glucose (mmol/L/hrs) | 6 hours |
| Incremental Area Under the Curve (iAUC) for insulin | Incremental Area Under the Curve (iAUC) for insulin (pmol/L/hrs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EB UtrechtResearch BV | Utrecht | Netherlands |
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Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
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| Second concept product (containing 50 grams of carbohydrates) | Dietary Supplement | Fasted intake Second concept product (randomised) |
|
| Reference product (containing 50 grams of carbohydrates) | Dietary Supplement | Fasted intake of Reference product (randomised) |
|
| 6 hours |
| Incremental Area Under the Curve (iAUC) for paracetamol | Incremental Area Under the Curve (iAUC) for paracetamol (pmol/L/hrs) | 6 hours |
| Incremental peak levels (iCmax) of glucose | Incremental peak levels (iCmax) of glucose (mmol/L) | 6 hours |
| Incremental peak levels (iCmax) of insulin | Incremental peak levels (iCmax) of insulin (pmol/L) | 6 hours |
| Incremental peak levels (iCmax) of paracetamol | Incremental peak levels (iCmax) of paracetamol (mg/L) | 6 hours |
| Time to peak levels (Tmax) of glucose | Time to peak levels (Tmax) of glucose (min) | 6 hours |
| Time to peak levels (Tmax) of insulin | Time to peak levels (Tmax) of insulin (min) | 6 hours |
| Time to peak levels (Tmax) of paracetamol | Time to peak levels (Tmax) of paracetamol (min) | 6 hours |
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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