NCT00114907

Brief Summary

It is proposed to investigate the association between consumption of black tea and various selective fasting blood serum and urine biomarkers in a Mauritian population with ischaemic heart diseases. This study, the first of its kind, will provide clinical data on the potential prophylactic propensities of Mauritian black tea against cardiovascular disease, which remains one of the major health threats to the Mauritian population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2005

Completed
Last Updated

April 6, 2007

Status Verified

June 1, 2005

First QC Date

June 17, 2005

Last Update Submit

April 5, 2007

Conditions

Cardiac Disease

Keywords

TeaOxidative stress markerscardiovascular diseasepolyphenolicsdouble blindIschaemic cardiac disease

Outcome Measures

Primary Outcomes (1)

  • The study will assess the effect of tea consumption on the incidence of cardiovascular diseases

Secondary Outcomes (1)

  • The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease

Interventions

Consumption of black teaBEHAVIORAL

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Non smokers
  • Left ventricular ejection fraction\>40%

You may not qualify if:

  • Alcohol consumption \> 4 standard drinks/day
  • Postmenopausal women receiving hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mauritius

Réduit, Mauritius

Location

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Theeshan Bahorun, PhD

    University of Mauritius

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2005

First Posted

June 20, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 6, 2007

Record last verified: 2005-06

Locations

MA(1)