Overview

This trial is active, not recruiting.

Condition pre-hypertension
Treatments strawberry beverage, placebo
Sponsor University of California, Davis
Collaborator California Strawberry Commission
Start date September 2007
End date October 2011
Trial size 50 participants
Trial identifier NCT01190319, 200715153

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Placebo Comparator)
The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.
placebo Beverage
Placebo beverage, 8 weeks
(Experimental)
The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.
strawberry beverage Strawberry powder made from a mix of California strawberries.
Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder

Primary Outcomes

Measure
Change in blood pressure
time frame: 8 weeks

Secondary Outcomes

Measure
Change in low density lipoprotein (LDL) oxidation
time frame: 8 weeks
Change in flow mediated dilation (FMD)
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

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

Additional Information

Official title Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension
Principal investigator Chulani T Kappagoda, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by University of California, Davis.