Whole Milk Intake and Cardio-metabolic Risk Factors

June 24, 2016 updated by: Liegang Liu, Huazhong University of Science and Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Jiawei Yin, PhD
        • Principal Investigator:
          • Xiaoqin Li, PhD
        • Principal Investigator:
          • Zhilei Shan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in body weight
Time Frame: 4 weeks
4 weeks
Change in body composition (body fat mass and lean mass)
Time Frame: 4 weeks
Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)
4 weeks
Changes in blood pressure
Time Frame: 4 weeks
Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention
4 weeks
Changes in blood lipids profile
Time Frame: 4 weeks
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention
4 weeks
Changes in fasting plasma glucose
Time Frame: 4 weeks
4 weeks
Changes in fasting plasma insulin
Time Frame: 4 weeks
4 weeks
Changes in fasting plasma C-peptide
Time Frame: 4 weeks
4 weeks
Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)
Time Frame: 4 weeks
Insulin sensitivity measure derived from fasting glucose and insulin
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in pro-inflammatory markers
Time Frame: 4 weeks
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
Time Frame: 4 weeks
Fasting plasma MDA, oxidized LDL before and after milk intervention
4 weeks
Biomarkers in urine
Time Frame: 4 weeks
4 weeks
Changes in fecal fat excretion
Time Frame: 4 weeks
4 weeks
Changes in fecal short chain fatty acids (SCFA)
Time Frame: 4 weeks
Fecal acetate, propionate, butyrate before and after milk intervention
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Liegang Liu, PhD, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0214513214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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