The Effects of California Strawberries on Parameters of Cardiovascular Health

Cardiovascular Disease Clinical Trial

Official title:

The Effects of California Strawberries on Parameters of Cardiovascular Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705093
• Other study ID #: 333071
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2012
• Last updated: July 13, 2017
• Start date: May 2012
• Est. completion date: January 2015

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Childhood Obesity
• Pediatric Obesity

Intervention

Dietary Supplement:
• flavonoid-rich freeze-dried strawberry powder
50g of flavonoid-rich freeze-dried strawberry powder
• macronutrient-matched control powder
50g macronutrient-matched powder that will lack strawberry flavonoids

Locations

Country	Name	City	State
United States	Ragle Human Nutrition Research Center, Academic Surge, UC Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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