Whole Milk Intake and Cardio-metabolic Risk Factors
- Conditions
- Lactose MalabsorptionCardiovascular Disease
- Interventions
- Dietary Supplement: full-fat milk
- Registration Number
- NCT02798718
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Aged above 18 years of age
- Able to give informed connect
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lactose maldigesters full-fat milk Participants in arm 2 are also grouped as lactose maldigesters based on breath hydrogen test after a 25-g lactose load. The breath hydrogen excretion is not less than 20 ppm. lactose digesters full-fat milk Participants in arm 1 are grouped as lactose digesters based on breath hydrogen test after a 25-g lactose load. The breath hydrogen excretion is less than 20 ppm.
- Primary Outcome Measures
Name Time Method Changes in body weight 4 weeks Change in body composition (body fat mass and lean mass) 4 weeks Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)
Changes in blood pressure 4 weeks Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention
Changes in blood lipids profile 4 weeks Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention
Changes in fasting plasma glucose 4 weeks Changes in fasting plasma insulin 4 weeks Changes in fasting plasma C-peptide 4 weeks Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR) 4 weeks Insulin sensitivity measure derived from fasting glucose and insulin
- Secondary Outcome Measures
Name Time Method Changes in fecal short chain fatty acids (SCFA) 4 weeks Fecal acetate, propionate, butyrate before and after milk intervention
Changes in pro-inflammatory markers 4 weeks Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α before and after milk intervention
Changes in markers of oxidative stress 4 weeks Fasting plasma MDA, oxidized LDL before and after milk intervention
Biomarkers in urine 4 weeks Changes in fecal fat excretion 4 weeks
Trial Locations
- Locations (1)
Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China