NCT00175110

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 3, 2009

Status Verified

December 1, 2009

First QC Date

September 12, 2005

Last Update Submit

December 2, 2009

Conditions

Hypertension

Keywords

pre-hypertensionmild hypertension

Interventions

herbal therapy/botanical therapy (Hibiscus sabdariffa)BEHAVIORAL

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • 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. doi: 10.3945/jn.109.115097. Epub 2009 Dec 16.

    PMID: 20018807DERIVED

MeSH Terms

Conditions

HypertensionPrehypertension

Interventions

Phytotherapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jeffrey B Blumberg, Ph.D.

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 3, 2009

Record last verified: 2009-12

Locations

US(1)