The Effects of California Strawberries on Parameters of Cardiovascular Health

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT01705093
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity; Cardiovascular Disease	Dietary Supplement: flavonoid-rich freeze-dried strawberry powder; Dietary Supplement: macronutrient-matched control powder	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: The Effects of California Strawberries on Parameters of Cardiovascular Health
• Actual Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ragle Human Nutrition Research Center, Academic Surge, UC Davis	Davis	California	United States	95616

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT01705093
• Other Study ID Numbers: 333071
• First Posted: Oct 12, 2012
• Last Update Posted: Jul 14, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by University of California, Davis: strawberry, cardiovascular, obesity, adolescent
• Additional relevant MeSH terms: Cardiovascular Diseases; Pediatric Obesity

Study Results

No Results Posted as of Jul 14, 2017