Whole Milk Intake and Cardio-metabolic Risk Factors

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Lactose Malabsorption
• Intervention / Treatment: Dietary supplement: full-fat milk

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liegang Liu, PhD; Phone Number: +86-27-83650522; Email: liegangliu@gmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Huazhong University of Science and Technology
      • Contact: Liegang Liu, PhD; Phone Number: +86-27-83650522; Email: liegangliu@gmail.com
      • Principal Investigator: Jiawei Yin, PhD
      • Principal Investigator: Xiaoqin Li, PhD
      • Principal Investigator: Zhilei Shan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lactose digesters; 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.	Dietary supplement: full-fat milk; intake 250ml full-fat milk per day, do not intake any other dairy products
Active Comparator: lactose maldigesters; 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.	Dietary supplement: full-fat milk; intake 250ml full-fat milk per day, do not intake any other dairy products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight		4 weeks
Change in body composition (body fat mass and lean mass)	Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)	4 weeks
Changes in blood pressure	Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention	4 weeks
Changes in blood lipids profile	Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention	4 weeks
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)	Insulin sensitivity measure derived from fasting glucose and insulin	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pro-inflammatory markers	Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α before and after milk intervention	4 weeks
Changes in markers of oxidative stress	Fasting plasma MDA, oxidized LDL before and after milk intervention	4 weeks
Biomarkers in urine		4 weeks
Changes in fecal fat excretion		4 weeks
Changes in fecal short chain fatty acids (SCFA)	Fecal acetate, propionate, butyrate before and after milk intervention	4 weeks

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Chair: Liegang Liu, PhD, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Estimate): June 27, 2016
• Last Update Submitted That Met QC Criteria: June 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Cardiovascular Diseases; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: 0214513214