Clinical trial NCT02798718: Whole Milk Intake and Cardio-metabolic Risk Factors
Official title: Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactose Malabsorption
Cardiovascular Disease
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in body weight
timeFrame: 4 weeks
measure: Change in body composition (body fat mass and lean mass)
timeFrame: 4 weeks
measure: Changes in blood pressure
timeFrame: 4 weeks
measure: Changes in blood lipids profile
timeFrame: 4 weeks
measure: Changes in fasting plasma glucose
timeFrame: 4 weeks
measure: Changes in fasting plasma insulin
timeFrame: 4 weeks
measure: Changes in fasting plasma C-peptide
timeFrame: 4 weeks
measure: Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in pro-inflammatory markers
timeFrame: 4 weeks
measure: Changes in markers of oxidative stress
timeFrame: 4 weeks
measure: Biomarkers in urine
timeFrame: 4 weeks
measure: Changes in fecal fat excretion
timeFrame: 4 weeks
measure: Changes in fecal short chain fatty acids (SCFA)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Liegang Liu, PhD
role: STUDY_CHAIR
References: