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| Name | Class |
|---|---|
| Biofortis Innovation Services | INDUSTRY |
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The goal of this clinical trial is to determine postprandial responses to fruit juices.
Fruit juice is commonly consumed as a part of a balanced diet because of hydration, flavor, and nutrient content . Dietary Guidelines for Americans 2020-2025 recognizes 100% fruit juice as a nutrient-dense beverage that can contribute to fruit and nutrient intake . Liquid form of juices may lead to faster absorption and hormonal responses . Measuring these acute metabolic responses can help clarify the role of fruit juice in dietary patterns and metabolic health .
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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 6 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 6 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 6 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 |
|---|---|---|---|---|
| Beverage 1 | Dietary Supplement | Fruit juice with zero sugar |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose iAUC - 2 hours | Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose maximal concentration | Plasma glucose maximal concentration (Cmax) | 2 hours |
| Blood glucose time to max concentration | Plasma glucose time to Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen S Smith, PhD, RD | Contact | 508-946-7204 | ksmith@oceanspray.com | |
| Christina Khoo, PhD | Contact | 508-946-7925 | ckhoo@oceanspray.com |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Antoo, MD | Biofortis Innovation Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Innovation Services | Recruiting | Addison | Illinois | 60101 | United States |
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| Fourth product order: order not stated to protect study blinding |
| Experimental |
Participant will receive each of the 6 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 6 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 6 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. |
|
| Beverage 2 | Dietary Supplement | Fruit juice with low sugar - formulation 1 |
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| Beverage 3 | Dietary Supplement | Fruit juice with low sugar - formulation 2 |
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| Beverage 4 | Dietary Supplement | Fruit juice with full sugar |
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| Beverage 5 | Dietary Supplement | Fruit juice with full sugar |
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| Beverage 6 | Dietary Supplement | Glucose control beverage |
|
| 2 hours |
| Blood glucose change | Plasma glucose concentration change from (C-max) - (C-baseline)) | 2 hours |
| Blood insulin iAUC | Serum insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min | 2 hours |
| Blood insulin maximal concentration | Serum insulin maximal concentration (C-max) | 2 hours |
| Blood insulin time to max concentration | Serum insulin time to C-max | 2 hours |
| Blood insulin change | Serum insulin concentration change from (C-max - (C-baseline)) | 2 hours |
| GLP-1 iAUC | GLP-1 incremental area under the curve (iAUC) from pre-product consumption to 120 min | 2 hours |
| GLP-1 Maximal Concentration | GLP-1 maximal concentration (C-max) | 2 hours |
| GLP-1 Time to Max Concentration | GLP-1 time to C-max | 2 hours |
| GLP-1 Change | GLP-1 concentration change from (C-max - (C-baseline)) | 2 hours |