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

NCT ID: NCT01617525

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Korean Recommended Diet

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

Group Type: EXPERIMENTAL

Controlled Feeding Dietary Intervention

Intervention Type: OTHER

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.

US Recommended Diet

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

Group Type: ACTIVE_COMPARATOR

Controlled Feeding Dietary Intervention

Intervention Type: OTHER

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.

Typical American Diet

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

Group Type: ACTIVE_COMPARATOR

Controlled Feeding Dietary Intervention

Intervention Type: OTHER

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.

Interventions

Controlled Feeding Dietary Intervention

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.

Intervention Type: OTHER

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)
• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

References

Schroeder N, Park YH, Kang MS, Kim Y, Ha GK, Kim HR, Yates AA, Caballero B. A randomized trial on the effects of 2010 Dietary Guidelines for Americans and Korean diet patterns on cardiovascular risk factors in overweight and obese adults. J Acad Nutr Diet. 2015 Jul;115(7):1083-92. doi: 10.1016/j.jand.2015.03.023.

Reference Type: DERIVED

PMID: 26115560 (View on PubMed)

Other Identifiers

Korean Diet Study

Identifier Type: -

Identifier Source: org_study_id