Effect of Mediterranean Diet on Metabolic Parameters and Microbiome in Dyslipidemic Patients: Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
The purpose of this randomized cross-over clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation, metabolic risk and microbiome in patients with dyslipidemia.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One or more of this criteria (total cholesterol ≥ 200mg/dl, LDL- cholesterol ≥130 mg/dL, triglyceride ≥ 200mg/dl)
- •If woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug
- •Able to speak and read Korean
- •Able to comply with all required study procedures and schedule
- •Willing and able to give written informed consent
- •Participants who are not participating in other clinical trials.
排除标准
- •Participants with cancer treatment
- •Participants with uncontrolled hypertension (systolic blood pressure (SBP) >180 mmHg, or diastolic blood pressure (DBP) >120 mmHg)
- •Participants with uncontrolled diabetes or fasting glucose ≥ 200mg/dl)
- •Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL)
- •Participants with significant cardiovascular disease (ischemic heart disease or stroke)
- •Participants who are taking lipid-lowering medications.
- •Participants who are taking other clinical trial medications.
- •Participants with acute infectious disease such as pneumonia, acute gastroenteritis, and urinary tract infection.
- •Vegetarian (does not eat red meat, poultry or fish)
- •Participants with food allergy (sea food, fish, nuts, egg, meat, tomato, wheat, or soybean)
- •Participants who are not able to eat more than 10 mediterranean meal in a row.
- •Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
结局指标
主要结局
Change in body weight
时间窗: baseline, 4 weeks, 10 weeks
body weight (kg)
Change in fat mass
时间窗: baseline, 4 weeks, 10 weeks
fat mass (kg) measured by bioelectrical impedance analyzer
Change in muscle mass
时间窗: baseline, 4 weeks, 10 weeks
muscle mass (kg) measured by bioelectrical impedance analyzer
Change in leukocyte count
时间窗: baseline, 4 weeks, 10 weeks
leukocyte count (/μL)
Change in C-reactive protein
时间窗: baseline, 4 weeks, 10 weeks
C-reactive protein (mg/L)
Change in fasting glucose
时间窗: baseline, 4 weeks, 10 weeks
fasting glucose (mg/dL)
Change in insulin
时间窗: baseline, 4 weeks, 10 weeks
insulin (mcIU/mL)
次要结局
- Change in triglyceride(baseline, 4 weeks, 10 weeks)
- Change in high-density lipoprotein cholesterol (HDL-cholesterol)(baseline, 4 weeks, 10 weeks)
- Change in low-density lipoprotein cholesterol (LDL-cholesterol)(baseline, 4 weeks, 10 weeks)
- Change in gut microbiome(baseline, 4 weeks, 10 weeks)
- Change in metabolomic response(baseline, 4 weeks, 10 weeks)
研究者
Ji-Won Lee
Professor
Gangnam Severance Hospital