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

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Other: Controlled Feeding Dietary Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01617525

Korean Diet Study

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)
• Voluntary or involuntary weight loss of 10% of body weight within the last 12 months
• Self-report of alcohol or substance abuse within the past 12 months
• Donated blood during the 8 week period prior to the study
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study anticipation or the ability to follow the intervention protocol

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 3 patient groups

Korean Recommended Diet

Experimental group

Description:

A dietary pattern that follows the recommendations by the Korean Rural Development Administration.

Treatment:

Other: Controlled Feeding Dietary Intervention

US Recommended Diet

Active Comparator group

Description:

Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team.

Treatment:

Other: Controlled Feeding Dietary Intervention

Typical American Diet

Active Comparator group

Description:

Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America.

Treatment:

Other: Controlled Feeding Dietary Intervention