The Effects of California Strawberries on Parameters of Cardiovascular Health

NCT01705093 | Completed Phase 2

• 1 other identifier: 333071
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity; Cardiovascular Disease

Keywords

strawberry, cardiovascular, obesity, adolescent

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Flavonoid-rich freeze-dried strawberry powder

EXPERIMENTAL

50g of flavonoid-rich freeze-dried strawberry powder

Dietary Supplement: flavonoid-rich freeze-dried strawberry powder

macronutrient- matched control powder

PLACEBO COMPARATOR

50g macronutrient-matched control powder that will lack strawberry flavonoids

Dietary Supplement: macronutrient-matched control powder

Interventions

flavonoid-rich freeze-dried strawberry powder DIETARY_SUPPLEMENT

50g of flavonoid-rich freeze-dried strawberry powder

Flavonoid-rich freeze-dried strawberry powder

macronutrient-matched control powder DIETARY_SUPPLEMENT

50g macronutrient-matched powder that will lack strawberry flavonoids

macronutrient- matched control powder

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Human Nutrition Research Center, Academic Surge, UC Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Cardiovascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: October 12, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

US (1)