Back to resultsEffects of Black Tea Intake on Serum Lipids
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tea Treatment Group
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesterolemia focused on measuring serum lipids, cholesterol, serum cholesterol, black tea, flavonoids, crossover trial, randomized control trial, diet controlled
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)
Sites / Locations
- General Clinical Research Center, University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tea Treatment Group
Placebo Group
Arm Description
5 cups brewed tea beverage per day for 28 days, brewed from 700 mg of black tea solids per cup
5 cups tea-like placebo per day for 28 days. Placebo was exactly matched to tea except for flavonoid composition. Placebo was flavonoid-free.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01882283
First Posted
June 17, 2013
Last Updated
May 3, 2019
Sponsor
University of Minnesota
Collaborators
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT01882283
Brief Title
Effects of Black Tea Intake on Serum Lipids
Official Title
Effects of Black Tea Intake on Serum Lipids in Mildly Hypercholesterolemic Adults A Randomized Diet-controlled Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
serum lipids, cholesterol, serum cholesterol, black tea, flavonoids, crossover trial, randomized control trial, diet controlled
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tea Treatment Group
Arm Type
Experimental
Arm Description
5 cups brewed tea beverage per day for 28 days, brewed from 700 mg of black tea solids per cup
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
5 cups tea-like placebo per day for 28 days. Placebo was exactly matched to tea except for flavonoid composition. Placebo was flavonoid-free.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tea Treatment Group
Other Intervention Name(s)
Brewed black tea beverage
Intervention Description
This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Serum lipid levels
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron Gross, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25266246
Citation
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.
Results Reference
derived
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Effects of Black Tea Intake on Serum Lipids
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