Effect of Strawberries on Cardiovascular Disease Risk

Study Overview
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Brief Summary
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It is important to identify and evaluate foods, such as strawberries, that can improve established and emerging cardiovascular risk factors, such as postprandial lipid and glycemic responses, and vascular health. Postprandial derangements may affect multiple metabolic pathways that lead to increased arterial stiffness. Research has demonstrated the potential of strawberries to ameliorate postprandial responses to a high fat/high glucose meal. Further research is needed to demonstrate this effect in better controlled clinical studies and explore whether metabolic effects lead to improved arterial health. The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including lipids, insulin, glucose, and arterial stiffness and central blood pressure. The investigators hypothesize that the bioactive components of strawberry powder will attenuate postprandial lipemic and glycemic responses, as well as improve measures of arterial health.

Official Title
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Effects of a Freeze Dried Strawberry Powder on Postprandial Vascular Function and Blood Markers of Cardiovascular Risk

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Strawberry Meal
* Dietary Supplement: Control Meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-50 years of age LDL-C below 160 mg/dL Triglycerides below 350 mg/dL No stage II hypertension (BP below 160/100 mmHg) Not taking medication for elevated lipids, blood pressure, or glucose Exclusion Criteria: Allergies to strawberries Known intolerance to high fat meals History of cardiovascular disease, kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis Use of non-steroidal anti-inflammatory or immunosuppressant drugs Conditions requiring the use of steroids Use of medication or supplements for elevated lipids, blood pressure or glucose

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strawberry Meal<br>40 g freeze-dried strawberries included in test meal | Dietary Supplement: Strawberry Meal<br>* High-fat meal (50 g total fat) with 40 g freeze dried strawberry powder<br>|
| Placebo Comparator: Control Meal<br>Control consisting of matched test meal with strawberry flavoring instead of freeze-dried strawberry powder | Dietary Supplement: Control Meal<br>* High-fat meal (50 g total fat) with a matched placebo powder containing no strawberry bioactives<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in postprandial central blood pressure and arterial stiffness |  | 2 and 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial changes in insulin |  | 0, 0.5, 1, 2, and 4 hours | 
| Postprandial changes in glucose |  | 0, 0.5, 1, 2, and 4 hours | 
| Postprandial changes in markers of inflammation/oxidative stress |  | 0, 0.5, 1, 2, and 4 hours | 
| Change from baseline in postprandial triglycerides at 0.5, 1, 2, and 4 hours |  | 0.5, 1, 2, and 4 hours |