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Whole Milk Intake and Cardio-metabolic Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02798718
Recruitment Status : Unknown
Verified June 2016 by Liegang Liu, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : June 14, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Liegang Liu, Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Lactose Malabsorption Cardiovascular Disease Dietary Supplement: full-fat milk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion
Study Start Date : May 2016
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes in body weight [ Time Frame: 4 weeks ]
  2. 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)

  3. Changes in blood pressure [ Time Frame: 4 weeks ]
    Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention

  4. 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

  5. Changes in fasting plasma glucose [ Time Frame: 4 weeks ]
  6. Changes in fasting plasma insulin [ Time Frame: 4 weeks ]
  7. Changes in fasting plasma C-peptide [ Time Frame: 4 weeks ]
  8. Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR) [ Time Frame: 4 weeks ]
    Insulin sensitivity measure derived from fasting glucose and insulin


Secondary Outcome Measures :
  1. 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

  2. Changes in markers of oxidative stress [ Time Frame: 4 weeks ]
    Fasting plasma MDA, oxidized LDL before and after milk intervention

  3. Biomarkers in urine [ Time Frame: 4 weeks ]
  4. Changes in fecal fat excretion [ Time Frame: 4 weeks ]
  5. Changes in fecal short chain fatty acids (SCFA) [ Time Frame: 4 weeks ]
    Fecal acetate, propionate, butyrate before and after milk intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798718


Contacts
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Contact: Liegang Liu, PhD +86-27-83650522 liegangliu@gmail.com

Locations
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China, Hubei
Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Liegang Liu, PhD    +86-27-83650522    liegangliu@gmail.com   
Principal Investigator: Xiaoqin Li, PhD         
Principal Investigator: Zhilei Shan, PhD         
Principal Investigator: Jiawei Yin, PhD         
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Chair: Liegang Liu, PhD Huazhong University of Science and Technology

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Responsible Party: Liegang Liu, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02798718    
Other Study ID Numbers: 0214513214
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Malabsorption Syndromes
Lactose Intolerance
Cardiovascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn