Study: Effects of Strawberries on Blood Pressure

Not Applicable

Completed

• Conditions: Pre-hypertension
• Interventions: Other: Placebo; Other: Strawberry Beverage

• Registration Number: NCT01190319
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Primary Completion: 2011-10
• Study Completion: 2015-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Beverage	Placebo	The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.
Strawberry Beverage	Strawberry Beverage	The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in low density lipoprotein (LDL) oxidation	8 weeks
Change in flow mediated dilation (FMD)	8 weeks

Trial Locations

Locations (1)

University of California Davis (Ragle Hall); 🇺🇸 Davis, California, United States