Matrix on Fruit Constituent Bioavailability (FRT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01908634|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2013
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy Non-smoker||Dietary Supplement: Milk-based Strawberry Beverage Dietary Supplement: Water-Based Strawberry Beverage Dietary Supplement: Milk-based Fruit-Mixed Beverage Dietary Supplement: Water-Based Fruit-Mixed Beverage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Pilot Study to Test the Effects of Matrix on Fruit Constituent Bioavailability and Influence on Chronic Disease Risk Factors.|
|Actual Study Start Date :||July 1, 2013|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: Milk-based Strawberry Beverage
Strawberry beverage with milk
Dietary Supplement: Milk-based Strawberry Beverage
Experimental: Water-based Strawberry Beverage
Strawberry beverage with water
Dietary Supplement: Water-Based Strawberry Beverage
Active Comparator: Milk-based Fruit-mixed Beverage
Fruit-Mixed beverage with milk
Dietary Supplement: Milk-based Fruit-Mixed Beverage
Experimental: Water-based Fruit-Mixed Beverage
Fruit-Mixed beverage with Water
Dietary Supplement: Water-Based Fruit-Mixed Beverage
- Changes in polyphenol anthocyanin concentrations [ Time Frame: 6 hours ]Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect, iAUC, total AUC, Cmax and TMax
- Changes in insulin concentrations [ Time Frame: 6 hours ]Changes in Plasma insulin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by time and treatment effect, iAUC, total AUC, Cmax and TMax
- Changes in Plasma cholesterol Concentrations (LDL, Triglycerides, and Total Cholesterol) [ Time Frame: Postprandial 6 hours ]Changes in Plasma cholesterol concentrations (LDL, triglycerides, and total cholesterol)over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect, iAUC
- Changes in plasma glucose concentrations [ Time Frame: Postprandial 6 hours ]Changes in Plasma glucose concentrations over 6hr (from 0 to 6 hrs), assessed by time and treatment effect, iAUC, total AUC, Cmax and TMax
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908634
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|Principal Investigator:||Britt Burton-Freeman, Ph.D||Illinois Institute of Technology|