Clinical trial NCT01882283: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: serum lipids
cholesterol
serum cholesterol
black tea
flavonoids
crossover trial
randomized control trial
diet controlled
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2013-06-20
Enrollment: 57
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Serum lipid levels
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: General Clinical Research Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Myron Gross, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.