The Effects of Strawberries on Blood Cholesterol.
- Conditions
- Hyper-LDL-cholesterolemiaMetabolic Syndrome
- Interventions
- Other: Control powderDietary Supplement: strawberries
- Registration Number
- NCT03441620
- Lead Sponsor
- University of Nevada, Las Vegas
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- elevated total and LDL cholesterol (>116 mg/dL)
- body mass index (> or = 30 kg/m2)
- features of the metabolic syndrome
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control Control powder Calorie and fiber-matched control powder Strawberry one serving strawberries Freeze-dried powder equivalent to one serving fresh strawberries per day. Strawberry two-half servings strawberries Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.
- Primary Outcome Measures
Name Time Method Serum Lipid profiles 14 weeks Serum LDL, total and HDL cholesterol, triglycerides
Serum lipid particle concentrations 14 weeks Molar concentrations of serum lipids and particle size
Glycemic control 14 weeks Blood glucose
Diabetes control 14 weeks Insulin resistance
- Secondary Outcome Measures
Name Time Method Systemic Inflammation 14 weeks Serum C-reactive protein and adipokines
Serum metabolomics 14 weeks primary and lipid metabolites in serum
Systemic Anthocyanins 14 weeks Strawberry anthocyanin metabolites measured in serum
Trial Locations
- Locations (3)
University of Oklahoma Health Sciences Center, OCTSI
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma State University
🇺🇸Stillwater, Oklahoma, United States
University of Nevada at Las Vegas
🇺🇸Las Vegas, Nevada, United States