Effect of an Extract of Green Tea on Adults With Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT00389350|
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : October 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Drug: Extract of Green and Black Tea||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of an Extract of Green Tea on Glucose Control in Adults With Type 2 Diabetes|
|Study Start Date :||August 2005|
|Estimated Study Completion Date :||June 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389350
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Todd A MacKenzie, PhD||Dartmouth-Hitchcock Medical Center|