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Effects of Black Tea Intake on Serum Lipids

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: Tea Treatment Group
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01882283
M01RR000400 (U.S. NIH Grant/Contract)
10205345-A2

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

57 participants in 2 patient groups, including a placebo group

Tea Treatment Group
Experimental group
Description:
5 cups brewed tea beverage per day for 28 days, brewed from 700 mg of black tea solids per cup
Treatment:
Dietary Supplement: Tea Treatment Group
Placebo Group
Placebo Comparator group
Description:
5 cups tea-like placebo per day for 28 days. Placebo was exactly matched to tea except for flavonoid composition. Placebo was flavonoid-free.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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