Effect of an Extract of Green Tea on Adults With Type 2 Diabetes

October 12, 2023 updated by: Todd MacKenzie, Dartmouth-Hitchcock Medical Center

The Effect of an Extract of Green Tea on Glucose Control in Adults With Type 2 Diabetes

The objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Recent evidence suggests that tea from Camellia Senensis (e.g., green, oolong and black tea) may have a hypoglycemic effect.

Objective: We evaluated the ability of an extract of green and black tea to improve glucose control over a three month period using a double blinded randomized multiple dose (either placebo, 375mg or 750mg) study in adults in with Type 2 Diabetes.

Patients: The 49 subjects who completed this study were predominantly whites with an average age of 65, a median duration of Diabetes of 6 years, and 80% reported using hypoglycemic medication.

Measurements: HbA1c at three months was the primary endpoint. Results: After three months the mean changes in HbA1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms, respectively. The changes were not significantly different between study arms.

Limitations: Evaluation of a particular extract that contained components of black teas as well as green tea. Power insufficient to detect changes in HbA1c < 0.5.

Conclusions: We did not find a hypoglycemic effect of extract of green tea in adults with Type 2 Diabetes, but cannot rule out the possibility that tea may have a small beneficial effect.

Study Type

Interventional

Enrollment

48

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults with Diabetes not taking insulin

Exclusion Criteria:

  • pregnancy, warfarin therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Todd A MacKenzie, PhD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimated)

October 18, 2006

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hitchcock Tea 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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