Effects of Black Tea Intake on Serum Lipids

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Black Tea Intake on Serum Lipids in Mildly Hypercholesterolemic Adults A Randomized Diet-controlled Crossover Trial

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Tea Treatment Group
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tea Treatment Group<br>5 cups brewed tea beverage per day for 28 days, brewed from 700 mg of black tea solids per cup | Dietary Supplement: Tea Treatment Group<br>* This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms<br>* Other names: Brewed black tea beverage;|
| Placebo Comparator: Placebo Group<br>5 cups tea-like placebo per day for 28 days. Placebo was exactly matched to tea except for flavonoid composition. Placebo was flavonoid-free. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lipid levels | 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 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serum lipids, cholesterol, serum cholesterol, black tea, flavonoids, crossover trial, randomized control trial, diet controlled