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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01190319
Other study ID # 200715153
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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