Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-13 @ 12:09 PM
Study NCT ID:
NCT01908634
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2013-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Matrix on Fruit Constituent Bioavailability
Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Organization:
Study Overview
Official Title:
A Pilot Study to Test the Effects of Matrix on Fruit Constituent Bioavailability and Influence on Chronic Disease Risk Factors.
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRT
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: