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Completed

NCT Number: NCT01617525

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled Feeding Dietary Intervention

Other

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.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. Markers of appetite and food intake regulation

    Time frame: End of each 4-week diet

    Plasma adiponectin, ghrelin, PYY and leptin will be measured.

  3. Blood pressure

    Time frame: End of each 4-week diet

  4. Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine

    Time frame: End of each 4-week diet

  5. 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.

  6. Dietary Questionnaires

    Time frame: At end of each 4-week diet

    Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 12, 2012
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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