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

May 10, 2016 updated by: USDA Beltsville Human Nutrition Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • USDA Beltsville Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Korean Recommended Diet
A dietary pattern that follows the recommendations by the Korean Rural Development Administration.
Other: 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.
Active Comparator: US Recommended Diet
Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team.
Other: 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.
Active Comparator: Typical American Diet
Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of each 4-week diet period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Markers
Time Frame: 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).
End of each 4-week diet
Markers of appetite and food intake regulation
Time Frame: End of each 4-week diet
Plasma adiponectin, ghrelin, PYY and leptin will be measured.
End of each 4-week diet
Blood pressure
Time Frame: End of each 4-week diet
End of each 4-week diet
Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine
Time Frame: End of each 4-week diet
End of each 4-week diet
Change in fecal microbiota
Time Frame: 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.
At baseline and after 4-weeks of each diet
Dietary Questionnaires
Time Frame: At end of each 4-week diet
Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.
At end of each 4-week diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Beltsville Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 31, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Korean Diet Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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