Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Carl Ade, M.S., Ph.D.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in plasma lipids
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.
Detailed Description
The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.
Investigators
Carl Ade, M.S., Ph.D.
Co-Principal Investigator
Kansas State University
Eligibility Criteria
Inclusion Criteria
- •Overweight or obese by BMI (25.0-34.9kg/m2),
- •Borderline-high LDL-cholesterol (130-159mg/dL),
- •Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)
Exclusion Criteria
- •known allergy or intolerance to strawberries
- •taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications
- •taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements
- •having anemia or any liver, thyroid, renal conditions
- •current smoker or user of tobacco products, or use within the past three months
- •consuming alcohol (\>1-2 drinks/day) on a regular basis
- •currently pregnant or lactating
- •having elevated blood pressure ≥130mmHg/≥80mmHg
- •presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions
- •total cholesterol ≥240mg/dL
Outcomes
Primary Outcomes
Change in plasma lipids
Time Frame: Week 0, 4, 5, 9, 10, and 14
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal
Secondary Outcomes
- Change in blood pressure (resting and 24-hr)(Week 0, 4, 5, 9, 10, and 14)
- Change in glucose and insulin response(Week 0, 4, 5, 9, 10, and 14)
- Change in homeostatic model assessment for insulin resistance(Week 0, 4, 5, 9, 10, and 14)
- Change in endothelial function(Week 0, 4, 5, 9, 10, and 14)
- Change in inflammation(Week 0, 4, 5, 9, 10, and 14)
- Change in arterial stiffness(Week 0, 4, 5, 9, 10, and 14)
- Change in oxidixed LDL(Week 0, 4, 5, 9, 10, and 14)