Effects of Low-fat Milk Consumption on Metabolic and Atherogenic Biomarkers in Korean Adults With Metabolic Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- inflammation markers
研究概览
简要总结
This study aimed to investigate the effects of low-fat milk consumption on metabolic parameters and biomarkers related to inflammation, oxidative stress, and endothelial function in Korean adults with metabolic syndrome.
详细描述
A randomized, controlled, parallel, dietary intervention study was designed. Subjects with metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the low-fat milk group, which were instructed to consume 2 packs of low-fat milk per day (200 mL twice daily) for 6 weeks, and the control group was instructed to maintain their habitual diet. Metabolic markers were evaluated at baseline and at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects were enrolled if their body mass index (BMI) was ≥23 kg/m2 and they met the criteria for metabolic syndrome.
排除标准
- •Those who were allergic to milk; those who had a history of digestive disorder; those with a medical history of cardiovascular diseases, including coronary artery diseases, valvular heart diseases, heart failure, or stroke; those who had cancer in the past 5 years; those who were taking hypoglycemic agents for diabetes mellitus; those who had chronic disease such as renal failure or liver cirrhosis; and those with a hemoglobin A1c (HbA1c) level ≥ 7% were excluded from the research. People who had a weight change > 5% of the total weight within the past 3 months, those who had started taking or had changed their dose of anti-hypertensive agents or medications for dyslipidemia within the previous 1 month, those who had a newly diagnosed dyslipidemia requiring drug treatment, those who had taken steroids either orally or by injection within the previous 3 months, those who were pregnant or were expecting to become pregnant; and those who regularly consumed milk in quantities ≥ 200 mL per day at least 3 times a week on average were also excluded.
结局指标
主要结局
inflammation markers
时间窗: 6 weeks
white blood cell count, high-sensitive C-reactive protein, Interleukin-6, adiponectin, serum and urine malondialdehyde, oxidized low-density lipoprotein, vascular cell adhesion molecule (VCAM) and intercellular adhesion molecule (ICAM)
Endo-peripheral artery tonometry (EndoPAT) index
时间窗: 6 weeks
EndoPAT index was assessed to evaluate endothelial function by using a finger plethysmograph based on non-invasive peripheral artery tonometry.
metabolic parameters
时间窗: 6 weeks
lipid profiles, body mass index, waist circumference, blood pressure, fasting glucose, insulin, hemoglobin A1c and homeostasis model assessment of insulin resistance
次要结局
未报告次要终点
研究者
Nan Hee Kim
Prof
Korea University