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Study: Effects of Strawberries on Blood Pressure (CSCBP)

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ClinicalTrials.gov Identifier: NCT01190319
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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 or disease Intervention/treatment
Pre-hypertension Other: Strawberry Beverage Other: Placebo

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension
Actual Study Start Date : September 2007
Primary Completion Date : October 2011
Study Completion Date : December 2015

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in blood pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in low density lipoprotein (LDL) oxidation [ Time Frame: 8 weeks ]
  2. Change in flow mediated dilation (FMD) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01190319     History of Changes
Other Study ID Numbers: 200715153
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases