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Effects of Black Tea Intake on Serum Lipids

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ClinicalTrials.gov Identifier: NCT01882283
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Tea Treatment Group Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Black Tea Intake on Serum Lipids in Mildly Hypercholesterolemic Adults A Randomized Diet-controlled Crossover Trial
Study Start Date : April 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tea Treatment Group
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
This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms
Other Name: Brewed black tea beverage

Placebo Comparator: Placebo Group
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



Primary Outcome Measures :
  1. Serum lipid levels [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882283


Locations
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United States, Minnesota
General Clinical Research Center, University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Myron Gross, PhD University of Minnesota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01882283    
Other Study ID Numbers: 10205345-A2
M01RR000400 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Keywords provided by University of Minnesota:
serum lipids
cholesterol
serum cholesterol
black tea
flavonoids
crossover trial
randomized control trial
diet controlled
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases