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The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure

Sponsor
Tufts University (Other)
Overall Status
Completed
CT.gov ID
NCT00175110
Collaborator
Celestial Seasonings (Industry), Tufts Medical Center (Other)
66
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: herbal therapy/botanical therapy (Hibiscus sabdariffa)
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Hibiscus Sabdariffa L. Tisane on Blood Pressure in Prehypertensive and Mildly Hypertensive Men and Women
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University Boston Massachusetts United States 02111

    Sponsors and Collaborators

    • Tufts University
    • Celestial Seasonings
    • Tufts Medical Center

    Investigators

    • Principal Investigator: Jeffrey B Blumberg, Ph.D., Tufts Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00175110
    Other Study ID Numbers:
    • PV3727
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Dec 3, 2009
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    pre-hypertension
    mild hypertension
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Dec 3, 2009