A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles

USDA Beltsville Human Nutrition Research Center1 site in 1 country29 target enrollmentJanuary 2012

ConditionsHypercholesterolemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypercholesterolemia
Sponsor: USDA Beltsville Human Nutrition Research Center
Enrollment: 29
Locations: 1
Primary Endpoint: Cardiovascular Disease Biomarkers
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary aim of this study is to compare, in a group of at-risk individuals, the role of three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended Korean pattern; b) the typical American diet, based on national dietary intake surveys; and c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on intestinal microbiota and on inflammatory biomarkers.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

May 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

USDA Beltsville Human Nutrition Research Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non Asian-American men and women between the ages of 25-65 years
•Body Mass Index (BMI) ≥ 25 and ≤ 38 kg/m2
•Fasting LDL-cholesterol ≥ 130 mg/dL
•Willingness and ability to make scheduled appointments at clinical site as required by study protocol

Exclusion Criteria

•Major aversions to Korean foods
•Known food allergies that would interfere with study protocol
•Use of cholesterol-lowering medication or dietary supplements
•Use of blood pressure medications
•Use of prebiotics or probiotics in the last 3 months
•Received medication for bacterial infection (antibiotic) in the last 3 months
•Regular use of fiber supplements or laxatives
•Conditions requiring ongoing medical care and/or medication, including kidney, liver, gastrointestinal or endocrine disorders.
•Regular tobacco use within 6 months prior to the start of the study
•History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)

Outcomes

Primary Outcomes

Cardiovascular Disease Biomarkers

Time Frame: End of each 4-week diet period

Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.

Secondary Outcomes

Inflammatory Markers(End of each 4-week diet)
Markers of appetite and food intake regulation(End of each 4-week diet)
Blood pressure(End of each 4-week diet)
Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine(End of each 4-week diet)
Change in fecal microbiota(At baseline and after 4-weeks of each diet)
Dietary Questionnaires(At end of each 4-week diet)