A Phase 2/3 interventional study of Extract of Green and Black Tea in Diabetes, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Dartmouth-Hitchcock Medical Center · Phase 2/3, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 48 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Also known as: Placebo Arm
HbA1c
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center