Effects of Black Tea Intake on Serum Lipids

NCT ID: NCT01882283

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2004-04-30

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Tea Treatment Group

5 cups brewed tea beverage per day for 28 days, brewed from 700 mg of black tea solids per cup

Group Type: EXPERIMENTAL

Tea Treatment Group

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Tea Treatment Group

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Brewed black tea beverage

Eligibility 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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myron Gross, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

General Clinical Research Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25266246 (View on PubMed)

Other Identifiers

M01RR000400

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10205345-A2

Identifier Type: -

Identifier Source: org_study_id