The Effects of California Strawberries on Parameters of Cardiovascular Health

NCT ID: NCT01705093

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Flavonoid-rich freeze-dried strawberry powder

50g of flavonoid-rich freeze-dried strawberry powder

Group Type: EXPERIMENTAL

flavonoid-rich freeze-dried strawberry powder

Intervention Type: DIETARY_SUPPLEMENT

50g of flavonoid-rich freeze-dried strawberry powder

macronutrient- matched control powder

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

Group Type: PLACEBO_COMPARATOR

macronutrient-matched control powder

Intervention Type: DIETARY_SUPPLEMENT

50g macronutrient-matched powder that will lack strawberry flavonoids

Interventions

flavonoid-rich freeze-dried strawberry powder

50g of flavonoid-rich freeze-dried strawberry powder

Intervention Type: DIETARY_SUPPLEMENT

macronutrient-matched control powder

50g macronutrient-matched powder that will lack strawberry flavonoids

Intervention Type: DIETARY_SUPPLEMENT

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).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ragle Human Nutrition Research Center, Academic Surge, UC Davis

Davis, California, United States

Countries

United States

Other Identifiers

333071

Identifier Type: -

Identifier Source: org_study_id