Study: Effects of Strawberries on Blood Pressure (CSCBP)

July 11, 2017 updated by: University of California, Davis

Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California Davis (Ragle Hall)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Strawberry powder made from a mix of California strawberries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in blood pressure
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in low density lipoprotein (LDL) oxidation
Time Frame: 8 weeks
8 weeks
Change in flow mediated dilation (FMD)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

California Strawberry Commission

Investigators

  • Principal Investigator: Chulani T Kappagoda, MD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2007

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

August 25, 2010

First Posted (ESTIMATE)

August 27, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200715153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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