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CompletedNCT01882283Updated May 7, 2019

Effects of Black Tea Intake on Serum Lipids

An interventional study of Tea Treatment Group and Placebo in Hypercholesterolemia, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • serum lipids
  • cholesterol
  • serum cholesterol
  • black tea
  • flavonoids
  • crossover trial
  • randomized control trial
  • diet controlled
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 57 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementTea Treatment Group

    This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms

    Also known as: Brewed black tea beverage

  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 weeks

07

Study locations

1 site
  • General Clinical Research Center, University of Minnesota
    Minneapolis, Minnesota 55454, United States
08

References and documents

Publications

  • Troup R, Hayes JH, Raatz SK, Thyagarajan B, Khaliq W, Jacobs DR Jr, Key NS, Morawski BM, Kaiser D, Bank AJ, Gross M. Effect of black tea intake on blood cholesterol concentrations in individuals with mild hypercholesterolemia: a diet-controlled randomized trial. J Acad Nutr Diet. 2015 Feb;115(2):264-271.e2. doi: 10.1016/j.jand.2014.07.021. Epub 2014 Sep 27. PubMed 25266246 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01882283
Lead sponsor
University of Minnesota
Collaborators
National Center for Research Resources (NCRR)
Responsible party
Sponsor
First posted
Jun 20, 2013
Start date
Apr 2002
Primary completion
Apr 2004
Completion
Apr 2004
Last update
May 7, 2019

Study contacts

Myron Gross, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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