NCT01617525已完成不适用
A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
USDA Beltsville Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Cardiovascular Disease Biomarkers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cardiovascular Disease Biomarkers
时间窗: End of each 4-week diet period
Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.
次要结局
- Inflammatory Markers(End of each 4-week diet)
- Markers of appetite and food intake regulation(End of each 4-week diet)
- Blood pressure(End of each 4-week diet)
- Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine(End of each 4-week diet)
- Change in fecal microbiota(At baseline and after 4-weeks of each diet)
- Dietary Questionnaires(At end of each 4-week diet)
研究者
研究点 (2)
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