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The primary aim of this clinical trial is to compare the effects of a whole orange, orange juice alone, and orange juice with pomace, and a whole apple, apple juice alone, apple juice with pomace on glycemic response. Fruit pomace is a fiber-rich byproduct that is isolated during normal juice production of fruits, such as orange and apple.
Study products are matched on total sugar and fiber. Phase I consists of 3 orange study products and Phase II consists of 3 apple study products. Subjects consume one fruit test portion or beverage test portion per visit day with at least a 3 day washout in between.
24 hr diet records are reviewed each test day to verify food and drink consistency and a diet containing at least 150 g of carbohydrate. Subjects arrive fasted (10-14 h, water only), are asked to maintain adequate hydration; and refrain from vigorous physical activity (24 h), alcohol consumption (24 h), and tobacco products (for at least 1 h).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole fruit 1 | Active Comparator | Oranges |
|
| Whole fruit 2 | Active Comparator | Apples |
|
| Juice 1 + pomace | Experimental | Orange Juice + orange pomace |
|
| Juice 2 + pomace | Experimental | Apple Juice + apple pomace |
|
| Juice 1 alone | Active Comparator | Orange Juice |
|
| Juice 2 alone | Active Comparator | Apple Juice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole oranges | Other | Navel oranges (227 g total) |
| |
| Whole Apples |
| Measure | Description | Time Frame |
|---|---|---|
| Positive incremental area under the curve (iAUC) for blood glucose | Blood serum | t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption |
| Measure | Description | Time Frame |
|---|---|---|
| iAUC0-120 min for insulin | Blood serum | t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption |
| Maximum concentration (Cmax) for blood glucose | Blood serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Lawless, 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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Conducted in 2 separate phases (1 phase/fruit) with 3 visits/phase
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| Other |
Red Delicious apple with skin (230 g) |
|
| Orange juice + orange pomace | Other | Orange Juice (149 g) + orange pomace (100g) [40% pomace by weight] |
|
| Apple juice + apple pomace | Other | Apple Juice (129 g) + apple pomace (106 g) [45% pomace by weight] |
|
| Orange juice | Other | Orange Juice (250 g) |
|
| Apple juice | Other | Apple Juice (235 g) |
|
| t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption |
| Time to maximum concentration (tmax) for blood glucose | Blood serum | t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption |
| Maximum concentration (Cmax) for insulin | Blood serum | t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption |
| Time to maximum concentration (tmax) for insulin | Blood serum | t = -15, -5, 15, 30, 45, 60, 90, and 120 min where t = 0 min is the start of study product consumption |