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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
33
Freeze-dried strawberry powder
Control powder matched for fiber and strawberries
University of Nevada at Las Vegas
Las Vegas, Nevada, United States
University of Oklahoma Health Sciences Center, OCTSI
Oklahoma City, Oklahoma, United States
Oklahoma State University
Stillwater, Oklahoma, United States
Serum Lipid profiles
Serum LDL, total and HDL cholesterol, triglycerides
Time frame: 14 weeks
Glycemic control
Blood glucose
Time frame: 14 weeks
Serum lipid particle concentrations
Molar concentrations of serum lipids and particle size
Time frame: 14 weeks
Diabetes control
Insulin resistance
Time frame: 14 weeks
Systemic Inflammation
Serum C-reactive protein and adipokines
Time frame: 14 weeks
Systemic Anthocyanins
Strawberry anthocyanin metabolites measured in serum
Time frame: 14 weeks
Serum metabolomics
primary and lipid metabolites in serum
Time frame: 14 weeks
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