The Effects of California Strawberries on Parameters of Cardiovascular Health

Phase 2

Completed

• Conditions: Childhood Obesity; Cardiovascular Disease
• Interventions: Dietary Supplement: macronutrient-matched control powder; Dietary Supplement: flavonoid-rich freeze-dried strawberry powder

• Registration Number: NCT01705093
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-12
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
macronutrient- matched control powder	macronutrient-matched control powder	50g macronutrient-matched control powder that will lack strawberry flavonoids
Flavonoid-rich freeze-dried strawberry powder	flavonoid-rich freeze-dried strawberry powder	50g of flavonoid-rich freeze-dried strawberry powder

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ragle Human Nutrition Research Center, Academic Surge, UC Davis; 🇺🇸 Davis, California, United States