The Effects of California Strawberries on Parameters of Cardiovascular Health

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.

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Key information

Conditions

Childhood Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

14 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Ragle Human Nutrition Research Center, Academic Surge, UC Davis

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

flavonoid-rich freeze-dried strawberry powder

Dietary Supplement

50g of flavonoid-rich freeze-dried strawberry powder

macronutrient-matched control powder

Dietary Supplement

50g macronutrient-matched powder that will lack strawberry flavonoids

Primary outcomes

Vascular function measured by peripheral arterial tonometry

Time frame: Change from baseline in vascular function at 1 hour and 1 week

Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Oct 12, 2012
Registry last updated: Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed