Status:
COMPLETED
Effects of Black Tea Intake on Serum Lipids
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
45-65 years
Phase:
NA
Brief Summary
A diet-controlled clinical trial which attempts to provide estimates of the effect of black tea consumption on serum lipids under tightly controlled conditions, including a controlled diet. Mildly hyp...
Eligibility Criteria
Inclusion
- between 45-65 years old
- mildly hypercholesterolemic (total cholesterol levels between 4.9 and 6.7 mmol/L, 190 and 260 mg/dl)
- high-density lipoprotein cholesterol (HDL-C) between 0.9 and 1.6 mmol/L (35 and 65 mg/dl)
- triglyceride (TG) concentrations below 6.8 mmol/L (600 mg/dl)
- habitually consumed a typical American diet with low dietary flavonoid intake (\<4 one-half cup servings of fruits and vegetables/day) and low intake (\<1 serving/day) of soy-rich foods, nuts, herbs, and spices (besides salt and pepper)
- aspartate aminotransferase (AST) between 0 and 55 mg/L
- creatinine between 70.7 and 150.3 mmol/L (0.8 and 1.7 mg/dl)
- glucose between 3.3 and 6.4 mmol/L (60 and 115 mg/dl)
Exclusion
- current smoker
- usage of high amounts of antioxidant vitamin supplements (\>3 times the Recommended Dietary Allowance (RDA) of vitamins E, C, and selenium, or \>10 mg/day of beta carotene)
- had been diagnosed with diabetes, coagulation disorders, chronic pulmonary disease, current active malignancy, renal disease requiring dialysis, malabsorption, or gastrointestinal disorders, or had a history of cardiovascular disease.
- antihypertensive, immunosuppressive, cholesterol lowering, or anticoagulant medications
- consuming \>3 servings of alcohol daily
- Pre-menopausal (women)
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01882283
Start Date
April 1 2002
End Date
April 1 2004
Last Update
May 7 2019
Active Locations (1)
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1
General Clinical Research Center, University of Minnesota
Minneapolis, Minnesota, United States, 55454