The Effects of California Strawberries on Parameters of Cardiovascular Health

Study Overview
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Brief Summary
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The prevalence of childhood obesity has been increasing over the past couple of decades. Similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea, citrus fruits, and strawberries are protective against the development of cardiovascular disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have observed that these isolated compounds, as well as strawberry extracts have the potential to affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in select measures of cardiovascular function in overweight and obese adolescent males.

Official Title
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The Effects of California Strawberries on Parameters of Cardiovascular Health

Conditions
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Childhood Obesity, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: flavonoid-rich freeze-dried strawberry powder
* Dietary Supplement: macronutrient-matched control powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects, age 14 - 18 years. BMI for age and gender >75th percentile (based on CDC growth charts) Subject is willing and able to comply with the study protocols. Exclusion Criteria: Inability to wear PAT probes Inability to remain still and remain quiet during test procedures BMI for age and gender ≤ 75th percentile (based on CDC growth charts) The use of medications that affect vascular function Regular use of dietary supplements during the last 6 months Blood pressure for age, gender and height ≥95th percentile Chronic/routine high intensity exercise or current participation in a sports program Self/Parent reported use of anticoagulation agents including NSAIDs Self/Parent reported use of oral cortisone or other immunosuppressive agents, Self/Parent reported underlying neoplasia or immunological disease Self/Parent reported diabetes Food faddists or those taking a non-traditional diet Allergies to fruit Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician. Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas). Asthma (can be worsened by mild to moderate food allergies).

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavonoid-rich freeze-dried strawberry powder<br>50g of flavonoid-rich freeze-dried strawberry powder | Dietary Supplement: flavonoid-rich freeze-dried strawberry powder<br>* 50g of flavonoid-rich freeze-dried strawberry powder<br>|
| Placebo Comparator: macronutrient- matched control powder<br>50g macronutrient-matched control powder that will lack strawberry flavonoids | Dietary Supplement: macronutrient-matched control powder<br>* 50g macronutrient-matched powder that will lack strawberry flavonoids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function measured by peripheral arterial tonometry | Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder | Change from baseline in vascular function at 1 hour and 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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strawberry, cardiovascular, obesity, adolescent