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

Phase 2
Completed
Conditions
Diabetes
Registration Number
NCT00389350
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Adults with Diabetes not taking insulin
Exclusion Criteria
  • pregnancy, warfarin therapy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
HbA1c
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

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