NCT01882283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

June 17, 2013

Last Update Submit

May 3, 2019

Conditions

Hypercholesterolemia

Keywords

serum lipidscholesterolserum cholesterolblack teaflavonoidscrossover trialrandomized control trialdiet controlled

Outcome Measures

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

    4 weeks

Study Arms (2)

Tea Treatment Group

EXPERIMENTAL

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 Group

PLACEBO COMPARATOR

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

Tea Treatment GroupDIETARY_SUPPLEMENT

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

Also known as: Brewed black tea beverage
Tea Treatment Group
PlaceboDIETARY_SUPPLEMENT
Placebo Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center, University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

  • 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.

    PMID: 25266246DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Myron Gross, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 20, 2013

Study Start

April 1, 2002

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

US(1)