Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion
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
- 是
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
Liegang Liu
Professor
Huazhong University of Science and Technology
