Effects of Black Tea on Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects of Black Tea Consumption on Oxidative Stress, Serum Lipid Profile and Insulin Sensitivity in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916188
• Other study ID #: P/25/47/4564
• Status: Completed
• Phase: N/A
• First received: June 8, 2009
• Last updated: July 26, 2010
• Start date: October 2006
• Est. completion date: November 2007

Study information

• Verified date: June 2009
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

• Intake of antioxidant supplements during previous six months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Black Tea Extract
Amount/dose depends on Arm assignment.

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity, oxidative Stress, lipid Profile		4 Weeks	Yes