Lactose Malabsorption, Cardiovascular Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTfull-fat milk
intake 250ml full-fat milk per day, do not intake any other dairy products
Sponsors
Huazhong University of Science and Technology
Study design
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged above 18 years of age * Able to give informed connect
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR) | 4 weeks | Insulin sensitivity measure derived from fasting glucose and insulin |
| 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
Countries
China
Contacts
Primary ContactLiegang Liu, PhD
Outcome results
None listed