Study: Effects of Strawberries on Blood Pressure

Study Overview
=================
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.

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

Conditions
-----------------
Pre-hypertension

Intervention / Treatment
-----------------
* Other: Strawberry Beverage
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Beverage<br>The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols. | Other: Placebo<br>* Placebo beverage, 8 weeks<br>* Other names: Beverage;|
| Experimental: Strawberry Beverage<br>The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols. | Other: Strawberry Beverage<br>* Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder<br>* Other names: Strawberry powder made from a mix of California strawberries.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure |  | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure, strawberry, fruit phenolics, LDL oxidation, Flow mediated dilation (FMD)