Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03441620 |
Other study ID # |
1119274 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2018 |
Est. completion date |
January 31, 2021 |
Study information
Verified date |
March 2021 |
Source |
University of Nevada, Las Vegas |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
In this study, we propose to investigate the effects of dietary achievable doses of
strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of
glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled
crossover study.
Description:
The screen visit will involve an 8 hour fasting state and the following procedures:
- Completing screening questionnaire
- Measuring height, weight, blood pressure, and waist size
- Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel
All subjects will be asked to follow usual diet and lifestyle, and refrain from other
sources of berries and related products while on the study. Subjects will also maintain
3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood
pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS
facility for clinical research). Blood draws will be performed by trained phlebotomists
(to be hired) at MPE 326, and all procedures will be performed by trained research
personnel [PI &Co-PI: Basu, Izuora and graduate student]. In case of blood pressure, an
average of at least three readings, 10 min apart, will be measured at each visit for
each participant. Blood glucose (fasting and postprandial at two hours) will be
determined at each time point. The oral glucose tolerance tests will be conducted at MPE
326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance
will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a
standard and widely used formula in calculating insulin resistance based on fasting
glucose values. Screening and follow-up tests will include clinical laboratory tests for
blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine
effects of the intervention.