Clinical trial NCT01617525: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2012-06-12
Enrollment: 29
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cardiovascular Disease Biomarkers
timeFrame: End of each 4-week diet period
Secondary outcomes:
measure: Inflammatory Markers
timeFrame: End of each 4-week diet
measure: Markers of appetite and food intake regulation
timeFrame: End of each 4-week diet
measure: Blood pressure
timeFrame: End of each 4-week diet
measure: Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine
timeFrame: End of each 4-week diet
measure: Change in fecal microbiota
timeFrame: At baseline and after 4-weeks of each diet
measure: Dietary Questionnaires
timeFrame: At end of each 4-week diet
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
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.