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Primary objective is to evaluate the influence of matrix on the bioavailability of key phytochemical constituents in fruits and their subsequent effect on chronic disease risk factors.
This study is a single-center, randomized, cross-over, 4-arm, single- blinded, 6-hour postprandial study to evaluate the effects of strawberry or comparator fruit provided in a formulated beverage with milk (as the base) or water or fresh/pureed.
A planned sample size of 10 men and women will be recruited into the study. Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic screening mechanisms, including questionnaires, fasting glucose concentration, and anthropometric measurements. Eligible subjects will be invited to participate in the study. Subjects will begin by completing a 3-day pre-study assessment of their usual dietary intake using 3-day food diary. After reviewing baseline food records, subjects will be instructed to avoid polyphenolic-containing foods for 2 days prior to the study visit, while maintaining their usual diet pattern and physical activity.
Subjects will participate in 6 h postprandial study days. Subjects will be randomized on the first day of starting the first post prandial visit day.
For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures published by our lab previously. This includes: pre-study evaluation for compliance (fasting, dinner consumption, limited polyphenol intake) and readiness for study visit, catheter placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate meal accompanied by 1 of the treatment beverages, subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time points for 6 hours.
Each postprandial study visit day will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois Institute of Technology main campus for the duration of the visit. The visit procedures are repeated four times ~ 1 week apart to accommodate subject testing with all four beverages; all procedures are identical on each postprandial study test visit with the exception that only an assigned test beverage per each visit will be consumed with the breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk-based Strawberry Beverage no meal | Active Comparator | Milk-based Strawberry beverage without meal |
|
| Water-based Strawberry Beverage no meal | Experimental | Water-based Strawberry beverage without meal |
|
| Milk-based strawberry Beverage with meal | Active Comparator | Milk-based Strawberry beverage with meal |
|
| Water-based strawberry Beverage with meal | Experimental | Water-based Strawberry beverage with meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk-based Strawberry Beverage without meal | Dietary Supplement |
| ||
| Water-Based Strawberry Beverage without meal |
| Measure | Description | Time Frame |
|---|---|---|
| CMax in Polyphenol Anthocyanin Concentrations | Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
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Eligible participants followed a low polyphenol diet 3 days before each test day visit (3 days run-in), while maintaining their usual diet and physical activity patterns.
Relatively healthy individuals were screened and recruited in Chicago, IL for the study at the Clinical Nutrition Research Center (CNRC) from 2013 to 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants received multiple interventions in *1* sequence (i.e., Water-based Strawberry Beverage With Meal first, then Milk-based Strawberry Beverage With Meal, then Water-based Strawberry Beverage Without Meal, then Milk-based Strawberry Beverage Without Meal) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Milk-based Strawberry Beverage With Meal |
| |||||||||||||
| Water-based Strawberry Beverage Wit Meal |
| |||||||||||||
| Milk-based Strawberry Beverage w/o Meal |
| |||||||||||||
| Water-based Strawberry Beverage w/o Meal |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants, measured at screening visit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CMax in Polyphenol Anthocyanin Concentrations | Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax | Nine subjects completed Part 1 (beverage with meal) and a subset of 4 completed Part 2 (beverages without meal). | Posted | Mean | Standard Error | nmol/L | 6 hours |
|
up to 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Without Meal | Milk-based strawberry Beverage without a meal vs. Water-based strawberry Beverage without a meal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Britt Burton-Freeman | Illinois Institute of Techology | 708-341-0178 | bburton@iit.edu |
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| ID | Term |
|---|---|
| D062407 | Meals |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Dietary Supplement |
|
| Milk-based strawberry Beverage with meal | Dietary Supplement |
|
| Water-Based strawberry Beverage with meal | Dietary Supplement |
|
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Milk-based Strawberry Beverage With Meal | Milk-based Strawberry beverage with meal Milk-based strawberry Beverage with meal |
| OG003 | Water-based Strawberry Beverage With Meal | Water-based Strawberry beverage with meal Water-Based strawberry Beverage with meal |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | With Meal | Milk-based strawberry Beverage with a meal vs. Water-based strawberry Beverage with a meal | 0 | 9 | 0 | 9 | 0 | 9 |
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