The Effects of California Strawberries on Parameters of Cardiovascular Health

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Childhood Obesity
• Intervention / Treatment: Dietary supplement: flavonoid-rich freeze-dried strawberry powder; Dietary supplement: macronutrient-matched control powder

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Ragle Human Nutrition Research Center, Academic Surge, UC Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flavonoid-rich freeze-dried strawberry powder; 50g of flavonoid-rich freeze-dried strawberry powder	Dietary supplement: flavonoid-rich freeze-dried strawberry powder; 50g of flavonoid-rich freeze-dried strawberry powder
Placebo Comparator: macronutrient- matched control powder; 50g macronutrient-matched control powder that will lack strawberry flavonoids	Dietary supplement: macronutrient-matched control powder; 50g macronutrient-matched powder that will lack strawberry flavonoids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: strawberry, cardiovascular, obesity, adolescent
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Cardiovascular Diseases; Pediatric Obesity
• Other Study ID Numbers: 333071