Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chronic Effects of Freeze-dried Strawberry Beverage on Cardiovascular Risk Factors in Subjects With Abdominal Adiposity and Dyslipidemia.

Conditions
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Dyslipidemia, Obesity

Intervention / Treatment
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* Dietary Supplement: Freeze-dried strawberries
* Dietary Supplement: Dietary fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: dyslipidemia abdominal adiposity (>35 inches for women, >40 inches for men) Exclusion Criteria: on statin therapy taking hypoglycemic agents

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose strawberry<br>50g freeze-dried strawberries/day | Dietary Supplement: Freeze-dried strawberries<br>* 25g or 50g freeze-dried strawberries reconstituted in water<br>|
| Experimental: Low-dose strawberry<br>25g freeze-dried strawberries/day | Dietary Supplement: Freeze-dried strawberries<br>* 25g or 50g freeze-dried strawberries reconstituted in water<br>|
| Other: Fiber/calorie control (high dose)<br>Dietary fiber (8g) | Dietary Supplement: Dietary fiber<br>* 4g or 8g dietary fiber blended in water<br>|
| Other: Fiber/calorie control (low dose)<br>Dietary fiber (4g) | Dietary Supplement: Dietary fiber<br>* 4g or 8g dietary fiber blended in water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids (mg/dL) | Change in lipids and lipoproteins at screen and 12 weeks of the study | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion molecules (ng/mL) | Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study. | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strawberries, Heart health, Anthocyanins