Whole Milk Intake and Cardio-metabolic Risk Factors

Huazhong University of Science and Technology

Status: Unknown

Conditions: Lactose Malabsorption; Cardiovascular Disease

Treatments: Dietary Supplement: full-fat milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02798718

0214513214

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

lactose digesters

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: full-fat milk

lactose maldigesters

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: full-fat milk