Study: Effects of Strawberries on Blood Pressure

Pre-hypertension Clinical Trial

— CSCBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190319
• Other study ID #: 200715153
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: July 11, 2017
• Start date: September 2007
• Est. completion date: December 2015

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-hypertension
• Prehypertension

Intervention

Other:
• Strawberry Beverage
Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder
• Placebo
Placebo beverage, 8 weeks

Locations

Country	Name	City	State
United States	University of California Davis (Ragle Hall)	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	California Strawberry Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure		8 weeks
Secondary	Change in low density lipoprotein (LDL) oxidation		8 weeks
Secondary	Change in flow mediated dilation (FMD)		8 weeks