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NCT00389350 Clinical Trial

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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389350
Other study ID # Hitchcock Tea 1
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date August 2005
Est. completion date June 2006

Study information
Verified date October 2023
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Adults with Diabetes not taking insulin Exclusion Criteria: - pregnancy, warfarin therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Extract of Green and Black Tea

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c
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