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The goal of this clinical trial is to compare the postprandial glucose and insulin responses after different fruit snacks compared to confection control in a healthy population
Fruit snacks made form sweetened dried fruits are great sources of polyphenols, fiber, and other nutrients. The addition of sugar could help the taste, texture, and shelf life of this type of product. Fruit snacks with different levels of sugar were developed to meet various consumer needs and the postprandial glucose response in healthy population compared with confection control is of interest to study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First product order: order not stated to protect study blinding | Experimental | Participant 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 | Participant 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 |
|
| Third product order: order not stated to protect study blinding | Experimental | Participant 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruit snack 1 | Dietary Supplement | Fruit snack with original level of sugar |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose iAUC - 2 hours | The primary outcome variable will be glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min (iAUC0-120 min) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose change | Plasma glucose concentration change (Cmax - Cbaseline) | 2 hours |
| blood glucose time to max concentration | Plasma glucose time to Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditi Shan, 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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Tested fruit bites are masked. Confection control is hard to mask (open label).
| Fourth product order: order not stated to protect study blinding | Experimental | Participant 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 | Participant 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 |
|
| Sixth product order: order not stated to protect study blinding | Experimental | Participant 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 snack with reduced level of sugar |
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| Fruit snack 3 | Dietary Supplement | Fruit snack with 0 added sugar - formulation 1 |
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| Fruit snack 4 | Dietary Supplement | Fruit snack with 0 added sugar - formulation 2 |
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| Fruit snack 5 | Dietary Supplement | Fruit snack from raisins |
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| Confection control | Dietary Supplement | confection |
|
| 2 hours |
| Blood insulin | Serum insulin iAUC, concentration change, time to the max concentration in 2 hours after consumption | 2 hours |