Effect of an Extract of Green Tea on Adults With Type 2 Diabetes
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|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)|
|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|
|Study Completion Date :||June 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|