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The goal of this clinical trial is to compare the postprandial glucose and insulin responses after different fruit snack consumption in a healthy population.
Fruit snacks made from sweetened dried fruits is a source of polyphenols, fiber, and other nutrients. The addition of sugar could aid in the taste, texture, and shelf life of these types of products. Fruit snacks with different levels of sugar were developed to meet various consumer needs. The postprandial glucose response in a healthy population is of interest in this regard.
Mulberry leaf extract has been shown the benefit of blood glucose regulation in multiple studies. This is mainly due to the function of the most predominant iminosugar, 1-deoxynojirimycin (DNJ), in the mulberry leaf extract which acts as α-glucosidase inhibitor. Fruit snacks containing mulberry leaf extract were developed and the postprandial metabolic response against a reference (white bread matched for carbohydrate) will be observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First product order: order not stated to protect study blinding | Experimental | Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence |
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| Second product order: order not stated to protect study blinding | Experimental | Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence |
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| Third product order: order not stated to protect study blinding | Experimental | Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence |
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| Fourth product order: order not stated to protect study blinding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruit snack 1 | Dietary Supplement | Fruit snacks with original level of sugar |
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose maximal concentration (Cmax) 2 hours after consumption | Glucose Cmax | 2 hour after consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min | Glucose iAUC | 2 hours |
| Glucose time to maximum concentration within 2 hours after consumption | Glucose Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Beckman, MD | Biofortis Innovation Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Innovation Services | Addison | Illinois | 60101 | United States |
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| Experimental |
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence |
|
| Fifth product order: order not stated to protect study blinding | Experimental | Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence |
|
| Fruit Snack 2 | Dietary Supplement | Fruit snacks with original level of sugar and mulberry leaf extract |
|
| Fruit Snack 3 | Dietary Supplement | Fruit snacks with reduced level of sugar |
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| Fruit Snack 4 | Dietary Supplement | Fruit snacks with zero added sugar |
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| White Bread | Dietary Supplement | White bread with matched carbohydrate as control |
|
| 2 hours |
| Insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min | Insulin iAUC | 2 hours |
| Insulin maximal concentration (Cmax) 2 hours after consumption | Insulin Cmax | 2 hours |
| Insulin time to maximum concentration within 2 hours after consumption | Insulin Tmax | 2 hours |