Whole Milk Intake and Cardio-metabolic Risk Factors

NCT02798718 | Unknown DMC

• 1 other identifier: 0214513214
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactose Malabsorption; Cardiovascular Disease

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Changes in pro-inflammatory markers

  4 weeks

• Changes in markers of oxidative stress

  4 weeks

• Biomarkers in urine

  4 weeks

• Changes in fecal fat excretion

  4 weeks

• Changes in fecal short chain fatty acids (SCFA)

  4 weeks

Study Arms (2)

lactose digesters

ACTIVE COMPARATOR

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

lactose maldigesters

ACTIVE COMPARATOR

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

Interventions

full-fat milk DIETARY_SUPPLEMENT

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

lactose digesters; lactose maldigesters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged above 18 years of age
• Able to give informed connect

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Lactose Intolerance; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Liegang Liu, PhD

  Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Liegang Liu, PhD

CONTACT

+86-27-83650522; liegangliu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2016
• Last Updated: June 27, 2016

Record last verified: 2016-06

Locations

CN (1)