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| Name | Class |
|---|---|
| California Strawberry Commission | OTHER |
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The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol, as well as blood pressure and arterial health.
The proposed study design is a 3-period randomized crossover dose-response study to evaluate the effect of freeze dried strawberry powder supplementation on LDL-C and vascular health. Research participants will be overweight or obese (BMI 25-39 kg/m^2) but otherwise healthy adults with moderately elevated LDL-C (>116 mg/dL or >3.0mmol/L), blood pressure <160/100 mmHg, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, and triglycerides below 350 mg/dL. Subjects will be randomly assigned to three supplementation periods: 1) low dose freeze dried strawberry powder (13 g/d); 2) high dose freeze dried strawberry powder (40 g/d); and 3) a placebo powder. Each powder will be provided for 4-6 weeks, separated by a 2-week washout period between treatment periods. Baseline and endpoint testing will include blood collection and vascular testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Strawberry Powder | Experimental | 40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder |
|
| High Dose Strawberry Powder | Experimental | 40 g freeze dried strawberry powder |
|
| Placebo Powder | Placebo Comparator | 40 g color and taste matched placebo powder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Strawberry Powder | Dietary Supplement | 40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C | LDL-C values calculated using the Friedewald equation | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Measure | Description | Time Frame |
|---|---|---|
| Central Blood Pressure | Aortic (central) blood pressure measured using the SphygmoCor System | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Peripheral Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny Kris-Etherton, PhD, RD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State CRC | University Park | Pennsylvania | 16803 | United States |
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| High Dose Strawberry Powder | Dietary Supplement | 40 g freeze dried strawberry powder |
|
| Placebo Powder | Dietary Supplement | 40 g color and taste matched placebo powder |
|
Peripheral blood pressure measured using the SphygmoCor System
| Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Augmentation Index | Augmentation index measured using the SphygmoCor System | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Pulse Wave Velocity | Pulse wave velocity measured using the SphygmoCor System | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Total Cholesterol | Total cholesterol values determined by enzymatic procedures | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Triglycerides | Triglyceride values determined using enzymatic procedures | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| HDL-C | HDL-C will be estimated according to the modified heparin-manganese procedure | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Oxidized LDL (oxLDL) | Plasma concentrations of oxLDL will be measured using ELISA kits | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| Malondialdehyde (MDA) | MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| High Sensitivity C Reactive Protein (hs-CRP) | hs-CRP will be measured by latex-enhanced immunonephelometry | Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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