Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors
- Conditions
- DyslipidemiaObesity
- Interventions
- Dietary Supplement: Freeze-dried strawberriesDietary Supplement: Dietary fiber
- Registration Number
- NCT01883401
- Lead Sponsor
- Oklahoma State University
- Brief Summary
Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5% significance level. We anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.
- Detailed Description
The overall objective of this clinical trial is to investigate the effects of low and high doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal adiposity and dyslipidemia versus age and gender-matched controls.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- dyslipidemia
- abdominal adiposity (>35 inches for women, >40 inches for men)
- on statin therapy
- taking hypoglycemic agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose strawberry Freeze-dried strawberries 50g freeze-dried strawberries/day Low-dose strawberry Freeze-dried strawberries 25g freeze-dried strawberries/day Fiber/calorie control (high dose) Dietary fiber Dietary fiber (8g) Fiber/calorie control (low dose) Dietary fiber Dietary fiber (4g)
- Primary Outcome Measures
Name Time Method Lipids (mg/dL) 2.5 years Change in lipids and lipoproteins at screen and 12 weeks of the study
- Secondary Outcome Measures
Name Time Method Adhesion molecules (ng/mL) 2.5 years Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.
Trial Locations
- Locations (1)
Oklahoma State University
🇺🇸Stillwater, Oklahoma, United States