Whole Milk Intake and Cardio-metabolic Risk Factors

NCT ID: NCT02798718

Last Updated: 2016-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lactose Malabsorption Cardiovascular Disease

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

full-fat milk

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

full-fat milk

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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full-fat milk

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Liegang Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liegang Liu, PhD

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

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Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liegang Liu, PhD

Role: CONTACT

+86-27-83650522

Facility Contacts

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Liegang Liu, PhD

Role: primary

+86-27-83650522

Other Identifiers

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0214513214

Identifier Type: -

Identifier Source: org_study_id

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