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

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

Tracking Information

• First Submitted Date: March 31, 2012
• First Posted Date: June 12, 2012
• Last Update Posted Date: May 11, 2016
• Study Start Date: January 2012
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01617525 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Hypercholesterolemia

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 11, 2012): 29
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01617525
• Other Study ID Numbers: Korean Diet Study
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: USDA Beltsville Human Nutrition Research Center
• Study Sponsor: USDA Beltsville Human Nutrition Research Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: USDA Beltsville Human Nutrition Research Center
• Verification Date: May 2016