Healthy Non-smoker
Conditions
Keywords
Bioavailability, Strawberry polyphenols, Fruit Beverage Matrix
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMilk-based Strawberry Beverage without meal
DIETARY_SUPPLEMENTWater-Based Strawberry Beverage without meal
DIETARY_SUPPLEMENTMilk-based strawberry Beverage with meal
DIETARY_SUPPLEMENTWater-Based strawberry Beverage with meal
Sponsors
Clinical Nutrition Research Center, Illinois Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult (18-78 years of age) * Relatively healthy * Non-smoker or past smoker with abstinence for at least 2 years
Exclusion criteria
* Pregnant and/or breast feeding * Smoker or past smoker with abstinence \<2 years * Allergy or intolerance to study foods * Current regular consumption of berries is \> 2 servings per day. * Fasting blood glucose ≥ 126 mg/dL. Subjects identified with elevated fasting blood glucose levels will be advised to contact their primary care physician for appropriate follow-up care. * Taking over the counter antioxidant supplements or other supplements that may interfere with the study procedures or endpoints. * Subjects with unusual dietary habits (e.g. pica). * Actively losing weight or trying to lose weight (unstable body weight fluctuations of \> 5 lbs in a 60 day period). * Excessive exercisers or trained athletes. * Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, or other systemic diseases. * Addicted to drugs and/or alcohol. * Medically documented psychiatric or neurological disturbances. * Severe obesity as defined by \>39.9 BMI or under weight for height (BMI \<18.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMax in Polyphenol Anthocyanin Concentrations | 6 hours | Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax |
Countries
United States
Participant flow
Recruitment details
Relatively healthy individuals were screened and recruited in Chicago, IL for the study at the Clinical Nutrition Research Center (CNRC) from 2013 to 2014
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants, measured at screening visit | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Milk-based Strawberry Beverage w/o Meal | Withdrawal by Subject | 5 |
| Water-based Strawberry Beverage Wit Meal | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous All | 24.5 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 9 |
| other Total, other adverse events | 0 / 4 | 0 / 9 |
| serious Total, serious adverse events | 0 / 4 | 0 / 9 |
Outcome results
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
Time frame: 6 hours
Population: Nine subjects completed Part 1 (beverage with meal) and a subset of 4 completed Part 2 (beverages without meal).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Milk-based Strawberry Beverage no Meal | CMax in Polyphenol Anthocyanin Concentrations | 8.7 nmol/L | Standard Error 0.7 |
| Water-based Strawberry Beverage no Meal | CMax in Polyphenol Anthocyanin Concentrations | 22.1 nmol/L | Standard Error 3.8 |
| Milk-based Strawberry Beverage With Meal | CMax in Polyphenol Anthocyanin Concentrations | 7.6 nmol/L | Standard Error 1.5 |
| Water-based Strawberry Beverage With Meal | CMax in Polyphenol Anthocyanin Concentrations | 11.3 nmol/L | Standard Error 2.7 |