Effects of Black Tea on Type 2 Diabetes

NCT ID: NCT00916188

Last Updated: 2010-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-11-30

Brief Summary

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The primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.

Detailed Description

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A total of 45 patients of known T2DM (16 males and 29 females) were introduced into the controlled clinical trial and randomly assigned to either test (57.0 ± 7.9 yrs, n=23) or control (55.4 •± 8.3 yrs, n=22) group. Patients in control group were instructed to have only one cup (150 ml) of black tea/day, as a 2.5 g tea bag that had to be prepared in a standard way for one week (washout period). Patients in the test group were instructed to have 300, 450, and 600 ml (2, 3, and 4 cups, respectively) in weeks 2, 3 and 4 respectively. We assessed the change in serum glutathion, superoxidismutase, total antioxidant capacity, FBS, CRP, HbA1C, lipid profiles and fibrinogen during the end of each week.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Black Tea-Four Doses

One, 2, 3 and 4 cups (150 ml/cup) of Black tea/day for week 1, 2, 3, and 4, respectively.

Group Type EXPERIMENTAL

Black Tea Extract

Intervention Type DIETARY_SUPPLEMENT

Amount/dose depends on Arm assignment.

Black Tea-One Dose

One cup (150 ml) of Black tea/day during study.

Group Type ACTIVE_COMPARATOR

Black Tea Extract

Intervention Type DIETARY_SUPPLEMENT

Amount/dose depends on Arm assignment.

Interventions

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Black Tea Extract

Amount/dose depends on Arm assignment.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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BTE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of type 2 diabetes mellitus

Exclusion Criteria

* Intake of antioxidant supplements during previous six months
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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National Nutrition and Food Technology Institute

Principal Investigators

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Tirang R. Neyestani, Ph.D.

Role: STUDY_CHAIR

National Nutrition & Food technology Research institute, Shaheed Beheshti University (M.C.), Islamic Republic of Iran,

Locations

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National Nutrition and Food Technology Research Institute

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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P/25/47/4564

Identifier Type: -

Identifier Source: org_study_id

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