Clinical trial NCT01705093: The Effects of California Strawberries on Parameters of Cardiovascular Health
Official title: The Effects of California Strawberries on Parameters of Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Childhood Obesity
Cardiovascular Disease
Keywords: strawberry, cardiovascular, obesity, adolescent
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 32
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Vascular function measured by peripheral arterial tonometry
timeFrame: Change from baseline in vascular function at 1 hour and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Ragle Human Nutrition Research Center, Academic Surge, UC Davis
state: California
Study officials:
References: