Effects of Black Tea on Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT00916188
First received: June 8, 2009
Last updated: July 26, 2010
Last verified: June 2009
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Dietary Supplement: Black Tea Extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of Black Tea Consumption on Oxidative Stress, Serum Lipid Profile and Insulin Sensitivity in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by National Nutrition and Food Technology Institute:

Primary Outcome Measures:
  • Insulin Sensitivity, oxidative Stress, lipid Profile [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: October 2006
Study Completion Date: November 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: Black Tea Extract
Amount/dose depends on Arm assignment.
Other Name: BTE
Active Comparator: Black Tea-One Dose
One cup (150 ml) of Black tea/day during study.
Dietary Supplement: Black Tea Extract
Amount/dose depends on Arm assignment.
Other Name: BTE

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

  • Intake of antioxidant supplements during previous six months
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00916188

Locations
Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of, 19395-4741
Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
Study Chair: Tirang R. Neyestani, Ph.D. National Nutrition & Food technology Research institute, Shaheed Beheshti University (M.C.), Islamic Republic of Iran,
  More Information

No publications provided

Responsible Party: Tirang reza Neyestani, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT00916188     History of Changes
Other Study ID Numbers: P/25/47/4564
Study First Received: June 8, 2009
Last Updated: July 26, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by National Nutrition and Food Technology Institute:
Black Tea
Oxidative Stress
Blood Lipids
Insulin Sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014