The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure

This study has been completed.

Sponsor:

Collaborators:

Celestial Seasonings

Tufts Medical Center

Information provided by:

Tufts University

ClinicalTrials.gov Identifier:

NCT00175110

First received: September 12, 2005

Last updated: December 2, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 2, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00175110 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure

Official Title ^ICMJE

The Effect of Hibiscus Sabdariffa L. Tisane on Blood Pressure in Prehypertensive and Mildly Hypertensive Men and Women

Brief Summary

The goal of this study is to find out whether the plant compounds present in Hibiscus sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a beneficial effect on blood pressure in people with mildly elevated blood pressure.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Behavioral: herbal therapy/botanical therapy (Hibiscus sabdariffa)

Study Arm (s)

Not Provided

Publications *

McKay DL, Chen CY, Saltzman E, Blumberg JB. Hibiscus sabdariffa L. tea (tisane) lowers blood pressure in prehypertensive and mildly hypertensive adults. J Nutr. 2010 Feb;140(2):298-303. Epub 2009 Dec 16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Systolic blood pressure 120-150 mm Hg
Diastolic blood pressure 95 mm Hg or less
Body mass index (BMI) 18.5-34.9 kg/m2

Exclusion Criteria:

Smoking
Use of medications that influence blood pressure
Cardiovascular disease
Chronic kidney disease
Diabetes
Regular use of vitamin C supplements (min 500 mg/day) within prior 30 days
Regular strenuous aerobic activity greater than 30 min/day
Excessive intake of caffeine or alcohol
Pregnancy within last 6 months or during study period
Abnormal complete blood count (CBC), urinalysis or electrocardiogram (EKG)

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00175110

Other Study ID Numbers ^ICMJE

PV3727

Has Data Monitoring Committee

Responsible Party

Jeffrey B. Blumberg, Tufts University

Study Sponsor ^ICMJE

Tufts University

Collaborators ^ICMJE

Celestial Seasonings
Tufts Medical Center

Investigators ^ICMJE

Principal Investigator:

Jeffrey B Blumberg, Ph.D.

Tufts Medical Center

Information Provided By

Tufts University

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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