Cardiovascular Disease, Childhood Obesity
Conditions
Keywords
strawberry, cardiovascular, obesity, adolescent
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTflavonoid-rich freeze-dried strawberry powder
50g of flavonoid-rich freeze-dried strawberry powder
DIETARY_SUPPLEMENTmacronutrient-matched control powder
50g macronutrient-matched powder that will lack strawberry flavonoids
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
14 Years to 18 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vascular function measured by peripheral arterial tonometry | 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 |
Countries
United States
Outcome results
None listed