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The Effects of California Strawberries on Parameters of Cardiovascular Health

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ClinicalTrials.gov Identifier: NCT01705093
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
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 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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




Primary Outcome Measures :
  1. Vascular function measured by peripheral arterial tonometry [ Time Frame: 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



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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705093


Locations
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United States, California
Ragle Human Nutrition Research Center, Academic Surge, UC Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01705093     History of Changes
Other Study ID Numbers: 333071
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Keywords provided by University of California, Davis:
strawberry, cardiovascular, obesity, adolescent
Additional relevant MeSH terms:
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Pediatric Obesity
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Nutrients
Growth Substances
Physiological Effects of Drugs