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Study: Effects of Strawberries on Blood Pressure (CSCBP)

Primary Purpose

Pre-hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strawberry Beverage
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pre-hypertension focused on measuring blood pressure, strawberry, fruit phenolics, LDL oxidation, Flow mediated dilation (FMD)

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis (Ragle Hall)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Beverage

Strawberry Beverage

Arm Description

The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.

The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.

Outcomes

Primary Outcome Measures

Change in blood pressure

Secondary Outcome Measures

Change in low density lipoprotein (LDL) oxidation
Change in flow mediated dilation (FMD)

Full Information

First Posted
October 20, 2009
Last Updated
July 11, 2017
Sponsor
University of California, Davis
Collaborators
California Strawberry Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01190319
Brief Title
Study: Effects of Strawberries on Blood Pressure
Acronym
CSCBP
Official Title
Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-hypertension
Keywords
blood pressure, strawberry, fruit phenolics, LDL oxidation, Flow mediated dilation (FMD)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Beverage
Arm Type
Placebo Comparator
Arm Description
The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.
Arm Title
Strawberry Beverage
Arm Type
Experimental
Arm Description
The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.
Intervention Type
Other
Intervention Name(s)
Strawberry Beverage
Other Intervention Name(s)
Strawberry powder made from a mix of California strawberries.
Intervention Description
Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Beverage
Intervention Description
Placebo beverage, 8 weeks
Primary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in low density lipoprotein (LDL) oxidation
Time Frame
8 weeks
Title
Change in flow mediated dilation (FMD)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: are taking over the counter anti-oxidant supplements, are taking prescription medications that may interfere with study procedures or endpoints, have unusual dietary habits (eg., pica), are actively losing weight or trying to lose weight, are addicted to drugs or alcohol, present with significant psychiatric or neurological disturbances, have known allergies to strawberry, will be excluded from participating in this study. Patients known to have glaucoma Pregnant and/or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulani T Kappagoda, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Britt Burton-Freeman, Ph.D
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis (Ragle Hall)
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

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Study: Effects of Strawberries on Blood Pressure

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