Hypercholesterolemia
Conditions
Keywords
serum lipids, cholesterol, serum cholesterol, black tea, flavonoids, crossover trial, randomized control trial, diet controlled
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 hypercholesterolemic individuals (total cholesterol levels between 4.9 and 6.7 mmol/L, 190 and 260 mg/dl), non-smoking, chronic disease-free individuals were enrolled in a 15-week, double blind, randomized crossover trial, during which they consumed a controlled low-flavonoid diet plus 5 cups of black tea or a tea-like placebo over two 4-week treatment periods.
Interventions
DIETARY_SUPPLEMENTTea Treatment Group
This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms
DIETARY_SUPPLEMENTPlacebo
Sponsors
National Center for Research Resources (NCRR)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum lipid levels | 4 weeks | Serum lipid levels (total cholesterol, LDL-C, HDL-C, triglycerides, LDL-C+HDL-C fraction, LDL-C/HDL-C ratio) were assessed at the end of a 28-day treatment period |
Countries
United States
Outcome results
None listed