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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617525
First Posted: June 12, 2012
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
USDA Beltsville Human Nutrition Research Center
  Purpose
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.

Condition Intervention
Hypercholesterolemia Other: Controlled Feeding Dietary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles

Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • Markers of appetite and food intake regulation [ Time Frame: End of each 4-week diet ]
    Plasma adiponectin, ghrelin, PYY and leptin will be measured.

  • Blood pressure [ Time Frame: End of each 4-week diet ]
  • Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine [ Time Frame: 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.

  • Dietary Questionnaires [ Time Frame: At end of each 4-week diet ]
    Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.


Enrollment: 29
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617525


Locations
United States, Maryland
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01617525     History of Changes
Other Study ID Numbers: Korean Diet Study
First Submitted: March 31, 2012
First Posted: June 12, 2012
Last Update Posted: May 11, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases