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Study: Effects of Strawberries on Blood Pressure (CSCBP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01190319
First received: October 20, 2009
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

The specific aim of the study is to determine whether a freeze dried powder provided by the California Strawberries Commission, can reduce blood pressure in patients with pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).


Condition Intervention
Pre-hypertension
Other: Strawberry Beverage
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in low density lipoprotein (LDL) oxidation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in flow mediated dilation (FMD) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2007
Estimated Study Completion Date: May 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Beverage
The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.
Other: Placebo
Placebo beverage, 8 weeks
Other Name: Beverage
Experimental: Strawberry Beverage
The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.
Other: Strawberry Beverage
Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder
Other Name: Strawberry powder made from a mix of California strawberries.

Detailed Description:

Primarily, we would like to find out whether freeze dried strawberry powder lowers blood pressure. In addition we would like to know if the strawberry alters the subject's blood cholesterol and the ability of the subject's blood vessels to relax.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-hypertensive men and women (JNC 7 [The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure] criteria) between the ages of 25 and 65 years who have no clinical evidence/history of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease.

Exclusion Criteria:

  • Subjects who:

    1. are taking over the counter anti-oxidant supplements,
    2. are taking prescription medications that may interfere with study procedures or endpoints,
    3. have unusual dietary habits (eg., pica),
    4. are actively losing weight or trying to lose weight,
    5. are addicted to drugs or alcohol,
    6. present with significant psychiatric or neurological disturbances,
    7. have known allergies to strawberry, will be excluded from participating in this study.
    8. Patients known to have glaucoma
    9. Pregnant and/or lactating females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190319

Locations
United States, California
University of California Davis (Ragle Hall)
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
California Strawberry Commission
Investigators
Principal Investigator: Chulani T Kappagoda, MD University of California, Davis
Principal Investigator: Britt Burton-Freeman, Ph.D University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01190319     History of Changes
Other Study ID Numbers: 200715153
Study First Received: October 20, 2009
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
blood pressure
strawberry
fruit phenolics
LDL oxidation
Flow mediated dilation (FMD)

Additional relevant MeSH terms:
Hypertension
Prehypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014