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

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ClinicalTrials.gov Identifier: NCT01617525
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
USDA Beltsville Human Nutrition Research Center

Tracking Information
First Submitted Date  ICMJE March 31, 2012
First Posted Date  ICMJE June 12, 2012
Last Update Posted Date May 11, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01617525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
Official Title  ICMJE A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Korean Recommended Diet
    A dietary pattern that follows the recommendations by the Korean Rural Development Administration.
    Intervention: Other: Controlled Feeding Dietary Intervention
  • Active Comparator: US Recommended Diet
    Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team.
    Intervention: Other: Controlled Feeding Dietary Intervention
  • Active Comparator: Typical American Diet
    Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America.
    Intervention: Other: Controlled Feeding Dietary Intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2012)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01617525
Other Study ID Numbers  ICMJE Korean Diet Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party USDA Beltsville Human Nutrition Research Center
Study Sponsor  ICMJE USDA Beltsville Human Nutrition Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account USDA Beltsville Human Nutrition Research Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP