Back to resultsA Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled Feeding Dietary Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Hypercholesterolemia
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
Sites / Locations
- USDA Beltsville Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Korean Recommended Diet
US Recommended Diet
Typical American Diet
Arm Description
A dietary pattern that follows the recommendations by the Korean Rural Development Administration.
Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team.
Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America.
Outcomes
Primary Outcome Measures
Cardiovascular Disease Biomarkers
Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.
Secondary Outcome Measures
Inflammatory Markers
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
Plasma adiponectin, ghrelin, PYY and leptin will be measured.
Blood pressure
Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine
Change in fecal microbiota
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
Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.
Full Information
NCT ID
NCT01617525
First Posted
March 31, 2012
Last Updated
May 10, 2016
Sponsor
USDA Beltsville Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01617525
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Beltsville Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Korean Recommended Diet
Arm Type
Experimental
Arm Description
A dietary pattern that follows the recommendations by the Korean Rural Development Administration.
Arm Title
US Recommended Diet
Arm Type
Active Comparator
Arm Description
Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team.
Arm Title
Typical American Diet
Arm Type
Active Comparator
Arm Description
Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America.
Intervention Type
Other
Intervention Name(s)
Controlled Feeding Dietary Intervention
Intervention Description
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 Outcome Measure Information:
Title
Cardiovascular Disease Biomarkers
Description
Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.
Time Frame
End of each 4-week diet period
Secondary Outcome Measure Information:
Title
Inflammatory Markers
Description
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).
Time Frame
End of each 4-week diet
Title
Markers of appetite and food intake regulation
Description
Plasma adiponectin, ghrelin, PYY and leptin will be measured.
Time Frame
End of each 4-week diet
Title
Blood pressure
Time Frame
End of each 4-week diet
Title
Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine
Time Frame
End of each 4-week diet
Title
Change in fecal microbiota
Description
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.
Time Frame
At baseline and after 4-weeks of each diet
Title
Dietary Questionnaires
Description
Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.
Time Frame
At end of each 4-week diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
USDA Beltsville Human Nutrition Research Center
City
Beltsville
State/Province
Maryland
ZIP/Postal Code
20705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26115560
Citation
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.
Results Reference
derived
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A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
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