Effects of Black Tea Intake on Serum Lipids

Hypercholesterolemia Clinical Trial

Official title:

Effects of Black Tea Intake on Serum Lipids in Mildly Hypercholesterolemic Adults A Randomized Diet-controlled Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882283
• Other study ID #: 10205345-A2
• Secondary ID: M01RR000400
• Status: Completed
• Phase: N/A
• Start date: April 2002
• Est. completion date: April 2004

Study information

• Verified date: May 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Tea Treatment Group
This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms
• Placebo

Locations

Country	Name	City	State
United States	General Clinical Research Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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