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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Other: Controlled Feeding Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean Recommended Diet<br>A dietary pattern that follows the recommendations by the Korean Rural Development Administration. | Other: Controlled Feeding Dietary Intervention<br>* All meals will be provided during each 4-week intervention period. Participants must consume all foods provided and must not consume any outside foods during each intervention period.<br>|
| Active Comparator: US Recommended Diet<br>Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team. | Other: Controlled Feeding Dietary Intervention<br>* All meals will be provided during each 4-week intervention period. Participants must consume all foods provided and must not consume any outside foods during each intervention period.<br>|
| Active Comparator: Typical American Diet<br>Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America. | Other: Controlled Feeding Dietary Intervention<br>* All meals will be provided during each 4-week intervention period. Participants must consume all foods provided and must not consume any outside foods during each intervention period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Disease Biomarkers | Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured. | End of each 4-week diet period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Markers | Cytokine production will be analyzed by selecting representative pro-inflammatory cytokine genes (i.e. TNF-a, IL-12, IL-6, IFNg), anti-inflammatory genes (IL-10), and different signaling pathways (i.e. Mitogen activated protein kinase (MAPK) p38, phosphatidylinositol 3 (PI3) kinase, and nuclear factor Kappa B (NF-KB). | End of each 4-week diet | 
| Markers of appetite and food intake regulation | Plasma adiponectin, ghrelin, PYY and leptin will be measured. | 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 | Fecal samples will be collected to study changes in bacterial abundance of commensal microorganisms such as Bifidobacterium spp., Lactobacillus spp., E.coli spp. and Bacteroides fragilis spp. | At baseline and after 4-weeks of each diet | 
| Dietary Questionnaires | Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms. | At end of each 4-week diet |