Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02167555 |
| Other study ID # |
2014-020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2014 |
| Est. completion date |
January 19, 2016 |
Study information
| Verified date |
January 2021 |
| Source |
Clinical Nutrition Research Center, Illinois Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Primary objective is to characterize the relative bioavailability and kinetic profile of wild
blueberry polyphenols over 24-hours period.
Secondary objective is to examine the relationship between bioavailability and kinetic
profile of wild blueberry polyphenols on markers of chronic diseases.
Description:
This study is a randomized, single blinded, 2-arm, within-subjects, placebo-controlled design
utilizing a multiple sampling, repeated measures paradigm to characterize the bioavailability
and kinetic profile of wild blueberry polyphenols.
A planned sample size of 12 will be enrolled into the study. This study will require one
initial screening visit, one pre-study visit, and 2 study visits. This study will take
approximately 3-4 weeks per subject to complete.
The initial screening visit will provide subject with the informed consent document and
determine subject eligibility through anthropometric measurements, vital signs, fasting blood
glucose test (finger prick), and completion of a survey relate to general eating, health, and
exercise habits.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day)
will be instructed at the Screening Visit and collected at the Pre-study visit to assess
subjects' baseline dietary intake pattern. Subjects will be instructed to follow a strictly
limited polyphenolic diet for 7 days prior to the study and throughout their participation
time, while maintaining their usual diet pattern and physical activity, with counseling by
staff investigator and/or Registered Dietitian. A dinner meal will be provided the day before
the study visit to control the second meal effect from the food and beverage intake of the
night before the study visit.
Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and
rested. Each study visit will require blood draws throughout the visit. After evaluation of
subject's health status (via anthropometric, vital sign and blood glucose measurements and
in-person interview), a registered nurse will place a catheter in subject's arm for the
purpose of multiple blood sample collections and take the initial blood draw in the fasting
state. Subjects will be randomized to receive a placebo or wild blueberry beverage treatment
based on randomized treatment sequences at 2 study visits along with 3 standard meals
(breakfast, lunch and dinner). The sequences of receiving the beverage treatments at each
visit will be randomly assigned to one of two of following sequences: placebo-wild blueberry
or wild blueberry-placebo.
Each study visit will involve with blood samples collection at time points 0 (fasting), 0.25,
0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hour (h) for assessment of change in plasma
metabolites of wild blueberry polyphenols and influence of metabolic and inflammation
markers. Also, urine samples will be collected prior to the study treatment as a baseline and
all voids over 6 time periods, 0 to 2 h, 2 to 4 h, 4 to 6 h, 6 to 8 h, 8 to 10h and 10 to 24
h during each study visit to assess wild blueberry polyphenolic metabolites.
