Effects of Black Tea Consumption on Oxidative Stress, Serum Lipid Profile and Insulin Sensitivity in Patients With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Insulin Sensitivity, oxidative Stress, lipid Profile
Study Overview
Brief Summary
The primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.
Detailed Description
A total of 45 patients of known T2DM (16 males and 29 females) were introduced into the controlled clinical trial and randomly assigned to either test (57.0 ± 7.9 yrs, n=23) or control (55.4 •± 8.3 yrs, n=22) group. Patients in control group were instructed to have only one cup (150 ml) of black tea/day, as a 2.5 g tea bag that had to be prepared in a standard way for one week (washout period). Patients in the test group were instructed to have 300, 450, and 600 ml (2, 3, and 4 cups, respectively) in weeks 2, 3 and 4 respectively. We assessed the change in serum glutathion, superoxidismutase, total antioxidant capacity, FBS, CRP, HbA1C, lipid profiles and fibrinogen during the end of each week.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of type 2 diabetes mellitus
Exclusion Criteria
- •Intake of antioxidant supplements during previous six months
Outcomes
Primary Outcomes
Insulin Sensitivity, oxidative Stress, lipid Profile
Time Frame: 4 Weeks
Secondary Outcomes
No secondary outcomes reported