Expired Study
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Davis, California 95616


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).


Study summary:

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.


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


Study is Available At:


Original ID:

200715153


NCT ID:

NCT01190319


Secondary ID:


Study Acronym:

CSCBP


Brief Title:

Study: Effects of Strawberries on Blood Pressure


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

25 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:September 2007
Completion Date:December 2015
Completion Type:Actual
Primary Completion Date:October 2011
Primary Completion Type:Actual
Verification Date:July 2017
Last Changed Date:July 11, 2017
First Received Date:October 20, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in flow mediated dilation (FMD)
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in low density lipoprotein (LDL) oxidation
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in blood pressure
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Strawberry Beverage
Description:Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder
Arm Name:Strawberry Beverage
Other Name:Strawberry powder made from a mix of California st
Intervention Type:Other
Name:Placebo
Description:Placebo beverage, 8 weeks
Arm Name:Placebo Beverage
Other Name:Beverage

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo Beverage
Description:The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.
Study Arm Type:Experimental
Arm Name:Strawberry Beverage
Description:The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis
Agency Class:Other
Agency Type:Collaborator
Agency Name:California Strawberry Commission

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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