Metabolic Syndrome, Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTActive strawberry powder
Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.
DIETARY_SUPPLEMENTPlacebo strawberry powder
Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.
DIETARY_SUPPLEMENTMixed strawberry powder
Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.
Sponsors
California Strawberry Commission
Carl Ade, M.S., Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The supplement and placebo will be distributed to the individual by a member of the research team who is not involved with data collection or analysis.
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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 * hemoglobin normal range values for males (between 13.0-17.5g/dL) and females (between 12.5-15.5g/dL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma lipids | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in oxidixed LDL | Week 0, 4, 5, 9, 10, and 14 | Obtained from blood sample in a fasted state and following consumption of a meal |
| Change in homeostatic model assessment for insulin resistance | Week 0, 4, 5, 9, 10, and 14 | Calculated from fasting glucose and insulin values |
| Change in inflammation | Week 0, 4, 5, 9, 10, and 14 | hs-CRP and IL-6 will be assessed in the fasted state from plasma |
| Change in glucose and insulin response | Week 0, 4, 5, 9, 10, and 14 | Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal |
| Change in blood pressure (resting and 24-hr) | Week 0, 4, 5, 9, 10, and 14 | Evaluated via automated sphygmomanometer. 24-hr ambulatory blood pressure is taken at 20-30 minute intervals over a 24hr period while the individual goes about their normal activities and while sleeping. |
| Change in endothelial function | Week 0, 4, 5, 9, 10, and 14 | Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion. |
| Change in arterial stiffness | Week 0, 4, 5, 9, 10, and 14 | Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms |
Countries
United States
Outcome results
None listed