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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Other: Controlled Feeding Dietary Intervention

• Registration Number: NCT01617525
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-31
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
US Recommended Diet	Controlled Feeding Dietary Intervention	Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team.
Korean Recommended Diet	Controlled Feeding Dietary Intervention	A dietary pattern that follows the recommendations by the Korean Rural Development Administration.
Typical American Diet	Controlled Feeding Dietary Intervention	Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America.

Primary Outcome Measures

Name	Time	Method
Cardiovascular Disease Biomarkers	End of each 4-week diet period	Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.

Secondary Outcome Measures

Name	Time	Method
Inflammatory Markers	End of each 4-week diet	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).
Markers of appetite and food intake regulation	End of each 4-week diet	Plasma adiponectin, ghrelin, PYY and leptin will be measured.
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	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.
Dietary Questionnaires	At end of each 4-week diet	Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.

Trial Locations

Locations (1)

USDA Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States