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临床试验/NCT02798718
NCT02798718Unknown不适用

Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Changes in body weight

研究概览

简要总结

Milk is the source of high-quality protein, calcium, and other vitamins and minerals. Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease. However, milk contains disaccharide lactose, which may cause gastrointestinal problems in those adults with poor digestion. Recent studies have shown that subjects with intolerance to lactose tend to reduce their consumption of milk. Actually, consumption of 12g lactose (240ml milk) per day produces negligible symptoms in lactose intolerant. Furthermore, a dairy-rich diet could improve lactose intolerance because of colonic adaption to it. Lactose maldigestion would not be a restricting factor in milk intake. In general, the undigested lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have beneficial effects on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal flora profile. But there are few studies evaluating effect of milk intake on health of people with lactose malabsorption or intolerance.This trial intend to study the effect of whole milk on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged above 18 years of age
  • Able to give informed connect

排除标准

  • Unwilling to trial dietary intervention
  • Pregnancy
  • Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
  • Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
  • Evidence of drug or alcohol abuse

结局指标

主要结局

Changes in body weight

时间窗: 4 weeks

Change in body composition (body fat mass and lean mass)

时间窗: 4 weeks

Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)

Changes in blood pressure

时间窗: 4 weeks

Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention

Changes in blood lipids profile

时间窗: 4 weeks

Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention

Changes in fasting plasma glucose

时间窗: 4 weeks

Changes in fasting plasma insulin

时间窗: 4 weeks

Changes in fasting plasma C-peptide

时间窗: 4 weeks

Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)

时间窗: 4 weeks

Insulin sensitivity measure derived from fasting glucose and insulin

次要结局

  • Changes in fecal short chain fatty acids (SCFA)(4 weeks)
  • Changes in pro-inflammatory markers(4 weeks)
  • Changes in markers of oxidative stress(4 weeks)
  • Biomarkers in urine(4 weeks)
  • Changes in fecal fat excretion(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liegang Liu

Professor

Huazhong University of Science and Technology

研究点 (1)

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Whole Milk Intake and Cardio-metabolic Risk Factors | 临床试验