Study: Effects of Strawberries on Blood Pressure

NCT ID: NCT01190319

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Pre-hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo Beverage

The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo beverage, 8 weeks

Strawberry Beverage

The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.

Group Type: EXPERIMENTAL

Strawberry Beverage

Intervention Type: OTHER

Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder

Interventions

Strawberry Beverage

Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder

Intervention Type: OTHER

Placebo

Placebo beverage, 8 weeks

Intervention Type: OTHER

Other Intervention Names

Strawberry powder made from a mix of California strawberries.; Beverage

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:

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Strawberry Commission

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chulani T Kappagoda, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Britt Burton-Freeman, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis (Ragle Hall)

Davis, California, United States

Countries

United States

Other Identifiers

200715153

Identifier Type: -

Identifier Source: org_study_id