The Effects of California Strawberries on Parameters of Cardiovascular Health

University of California (UC) Davis

Status and phase

Completed

Phase 2

Conditions

Childhood Obesity

Cardiovascular Disease

Treatments

Dietary Supplement: macronutrient-matched control powder

Dietary Supplement: flavonoid-rich freeze-dried strawberry powder

Study type

Interventional

Funder types

Other

Identifiers

NCT01705093

333071

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Male

Ages

14 to 18 years old

Volunteers

Accepts Healthy Volunteers

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).