Whole Milk Intake and Cardio-metabolic Risk Factors

Cardiovascular Disease Clinical Trial

Official title:

Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02798718
• Other study ID #: 0214513214
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2016
• Last updated: June 24, 2016
• Start date: May 2016

Study information

• Verified date: June 2016
• Source: Huazhong University of Science and Technology
• Contact: Liegang Liu, PhD
• Phone: +86-27-83650522
• Email: liegangliu[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Lactose Intolerance
• Lactose Malabsorption
• Malabsorption Syndromes

Intervention

Dietary Supplement:
• full-fat milk
intake 250ml full-fat milk per day, do not intake any other dairy products

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight		4 weeks	No
Primary	Change in body composition (body fat mass and lean mass)	Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)	4 weeks	No
Primary	Changes in blood pressure	Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention	4 weeks	No
Primary	Changes in blood lipids profile	Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention	4 weeks	No
Primary	Changes in fasting plasma glucose		4 weeks	No
Primary	Changes in fasting plasma insulin		4 weeks	No
Primary	Changes in fasting plasma C-peptide		4 weeks	No
Primary	Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)	Insulin sensitivity measure derived from fasting glucose and insulin	4 weeks	No
Secondary	Changes in pro-inflammatory markers	Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-a before and after milk intervention	4 weeks	No
Secondary	Changes in markers of oxidative stress	Fasting plasma MDA, oxidized LDL before and after milk intervention	4 weeks	No
Secondary	Biomarkers in urine		4 weeks	No
Secondary	Changes in fecal fat excretion		4 weeks	No
Secondary	Changes in fecal short chain fatty acids (SCFA)	Fecal acetate, propionate, butyrate before and after milk intervention	4 weeks	No