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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Caballero, United States Department of Agriculture
ClinicalTrials.gov Identifier:
NCT01617525
First received: March 31, 2012
Last updated: June 11, 2012
Last verified: June 2012
  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 Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Plasma adiponectin, ghrelin, PYY and leptin will be measured.

  • Blood pressure [ Time Frame: End of each 4-week diet ] [ Designated as safety issue: No ]
  • Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine [ Time Frame: End of each 4-week diet ] [ Designated as safety issue: No ]
  • Change in fecal microbiota [ Time Frame: At baseline and after 4-weeks of each diet ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Benjamin Caballero, Research Scientist, United States Department of Agriculture
ClinicalTrials.gov Identifier: NCT01617525     History of Changes
Other Study ID Numbers: Korean Diet Study
Study First Received: March 31, 2012
Last Updated: June 11, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 19, 2014