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Completed

NCT Number: NCT00916188

Effects of Black Tea on Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Nutrition and Food Technology Research Institute

Tehran, Tehran Province, 19395-4741, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of type 2 diabetes mellitus

Exclusion criteria

  • Intake of antioxidant supplements during previous six months

Treatment and study plan

Black Tea Extract

Dietary Supplement

Amount/dose depends on Arm assignment.

Other names: BTE

Primary outcomes

  1. Insulin Sensitivity, oxidative Stress, lipid Profile

    Time frame: 4 Weeks

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Jun 9, 2009
Registry last updated
Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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