Hyper-LDL-cholesterolemia, Metabolic Syndrome
Conditions
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTstrawberries
Freeze-dried strawberry powder
OTHERControl powder
Control powder matched for fiber and strawberries
Sponsors
University of Oklahoma
Oklahoma State University
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* elevated total and LDL cholesterol (\>116 mg/dL) * body mass index (\> or = 30 kg/m2) * features of the metabolic syndrome
Exclusion criteria
* taking glucose and lipid lowering medications (e.g. statins, metformin) * history of chronic conditions (diabetes, CHD, anemia, renal diseases) * allergic to strawberries * pregnant and/or lactating * smoking * vegetarian or consuming special diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Lipid profiles | 14 weeks | Serum LDL, total and HDL cholesterol, triglycerides |
| Glycemic control | 14 weeks | Blood glucose |
| Serum lipid particle concentrations | 14 weeks | Molar concentrations of serum lipids and particle size |
| Diabetes control | 14 weeks | Insulin resistance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Anthocyanins | 14 weeks | Strawberry anthocyanin metabolites measured in serum |
| Serum metabolomics | 14 weeks | primary and lipid metabolites in serum |
| Systemic Inflammation | 14 weeks | Serum C-reactive protein and adipokines |
Countries
United States
Outcome results
None listed