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Sponsored by: |
Dartmouth-Hitchcock Medical Center |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00389350 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes |
Drug: Extract of Green and Black Tea |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of an Extract of Green Tea on Glucose Control in Adults With Type 2 Diabetes |
Estimated Enrollment: | 48 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 |
Principal Investigator: | Todd A MacKenzie, PhD | Dartmouth-Hitchcock Medical Center |
Study ID Numbers: | Hitchcock Tea 1 |
Study First Received: | October 16, 2006 |
Last Updated: | October 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00389350 |
Health Authority: | United States: Institutional Review Board |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |