Whole Milk Intake and Cardio-metabolic Risk Factors
Primary Purpose
Lactose Malabsorption, Cardiovascular Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
full-fat milk
Sponsored by
About this trial
This is an interventional prevention trial for Lactose Malabsorption
Eligibility Criteria
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
Sites / Locations
- Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
lactose digesters
lactose maldigesters
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in body weight
Change in body composition (body fat mass and lean mass)
Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)
Changes in blood pressure
Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention
Changes in blood lipids profile
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention
Changes in fasting plasma glucose
Changes in fasting plasma insulin
Changes in fasting plasma C-peptide
Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)
Insulin sensitivity measure derived from fasting glucose and insulin
Secondary Outcome Measures
Changes in pro-inflammatory markers
Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α before and after milk intervention
Changes in markers of oxidative stress
Fasting plasma MDA, oxidized LDL before and after milk intervention
Biomarkers in urine
Changes in fecal fat excretion
Changes in fecal short chain fatty acids (SCFA)
Fecal acetate, propionate, butyrate before and after milk intervention
Full Information
NCT ID
NCT02798718
First Posted
May 24, 2016
Last Updated
June 24, 2016
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02798718
Brief Title
Whole Milk Intake and Cardio-metabolic Risk Factors
Official Title
Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Malabsorption, Cardiovascular Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lactose digesters
Arm Type
Active Comparator
Arm Description
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.
Arm Title
lactose maldigesters
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
full-fat milk
Intervention Description
intake 250ml full-fat milk per day, do not intake any other dairy products
Primary Outcome Measure Information:
Title
Changes in body weight
Time Frame
4 weeks
Title
Change in body composition (body fat mass and lean mass)
Description
Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)
Time Frame
4 weeks
Title
Changes in blood pressure
Description
Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention
Time Frame
4 weeks
Title
Changes in blood lipids profile
Description
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention
Time Frame
4 weeks
Title
Changes in fasting plasma glucose
Time Frame
4 weeks
Title
Changes in fasting plasma insulin
Time Frame
4 weeks
Title
Changes in fasting plasma C-peptide
Time Frame
4 weeks
Title
Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)
Description
Insulin sensitivity measure derived from fasting glucose and insulin
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in pro-inflammatory markers
Description
Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α before and after milk intervention
Time Frame
4 weeks
Title
Changes in markers of oxidative stress
Description
Fasting plasma MDA, oxidized LDL before and after milk intervention
Time Frame
4 weeks
Title
Biomarkers in urine
Time Frame
4 weeks
Title
Changes in fecal fat excretion
Time Frame
4 weeks
Title
Changes in fecal short chain fatty acids (SCFA)
Description
Fecal acetate, propionate, butyrate before and after milk intervention
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liegang Liu, PhD
Phone
+86-27-83650522
Email
liegangliu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liegang Liu, PhD
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liegang Liu, PhD
Phone
+86-27-83650522
Email
liegangliu@gmail.com
First Name & Middle Initial & Last Name & Degree
Xiaoqin Li, PhD
First Name & Middle Initial & Last Name & Degree
Zhilei Shan, PhD
First Name & Middle Initial & Last Name & Degree
Jiawei Yin, PhD
12. IPD Sharing Statement
Learn more about this trial
Whole Milk Intake and Cardio-metabolic Risk Factors
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