Clinical trial NCT01908634: Matrix on Fruit Constituent Bioavailability
Official title: A Pilot Study to Test the Effects of Matrix on Fruit Constituent Bioavailability and Influence on Chronic Disease Risk Factors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Non-smoker
Keywords: Bioavailability
Strawberry polyphenols
Fruit Beverage Matrix
Lead sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: CMax in Polyphenol Anthocyanin Concentrations
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Nutrition Research Center
state: Illinois
Study officials:
affiliation: Illinois Institute of Technology
name: Britt Burton-Freeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: