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The Effects of California Strawberries on Parameters of Cardiovascular Health

Primary Purpose

Childhood Obesity, Cardiovascular Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
flavonoid-rich freeze-dried strawberry powder
macronutrient-matched control powder
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring strawberry, cardiovascular, obesity, adolescent

Eligibility Criteria

14 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Ragle Human Nutrition Research Center, Academic Surge, UC Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Flavonoid-rich freeze-dried strawberry powder

macronutrient- matched control powder

Arm Description

50g of flavonoid-rich freeze-dried strawberry powder

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2012
Last Updated
July 13, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01705093
Brief Title
The Effects of California Strawberries on Parameters of Cardiovascular Health
Official Title
The Effects of California Strawberries on Parameters of Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Cardiovascular Disease
Keywords
strawberry, cardiovascular, obesity, adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flavonoid-rich freeze-dried strawberry powder
Arm Type
Experimental
Arm Description
50g of flavonoid-rich freeze-dried strawberry powder
Arm Title
macronutrient- matched control powder
Arm Type
Placebo Comparator
Arm Description
50g macronutrient-matched control powder that will lack strawberry flavonoids
Intervention Type
Dietary Supplement
Intervention Name(s)
flavonoid-rich freeze-dried strawberry powder
Intervention Description
50g of flavonoid-rich freeze-dried strawberry powder
Intervention Type
Dietary Supplement
Intervention Name(s)
macronutrient-matched control powder
Intervention Description
50g macronutrient-matched powder that will lack strawberry flavonoids
Primary Outcome Measure Information:
Title
Vascular function measured by peripheral arterial tonometry
Description
Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder
Time Frame
Change from baseline in vascular function at 1 hour and 1 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Ragle Human Nutrition Research Center, Academic Surge, UC Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of California Strawberries on Parameters of Cardiovascular Health

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