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出境医 / 临床实验 / Effect of Probiotics on Lipid Management

Effect of Probiotics on Lipid Management

Study Description
Brief Summary:
Dysbiosis of gut microbiota has been reported to be involved in the development of hypercholesterolemia in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate dyslipidemia in adults remain obscure.

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Dietary Supplement: Lactobacillus paracasei dietary supplement Other: Placebo controls Not Applicable

Detailed Description:
Probiotics are live microorganisms that have been associated with multiple health benefits. However, its protective role in adults has long been controversial. This study aims to examine the effect of 12-week probiotics supplementation on lipid management in Chinese adults. By understanding the mechanism by which probiotics exert the beneficial effects, we can better control the rising prevalence of hypercholesterolemia, which is a major risk factor for cardiovascular diseases.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo-controlled, randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
Primary Purpose: Prevention
Official Title: Role of Probiotics in the Management of Hypercholesterolemia
Actual Study Start Date : May 12, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Probiotics group
Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.
 Dietary Supplement: Lactobacillus paracasei dietary supplement
a commercial probiotic dietary supplement
Placebo Comparator: Placebo group
Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.
 Other: Placebo controls
placebo with a similar appearance to probiotics supplement
Outcome Measures
Primary Outcome Measures :
  1. Total cholesterol [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of total cholesterol levels in plasma by automatic biochemical analyzer

  2. LDL-cholesterol [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer

  3. Triglyceride [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of triglyceride levels in plasma by automatic biochemical analyzer

  4. non HDL-cholesterol [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of non HDL-cholesterol levels in plasma

  5. gut microbiota [ Time Frame: baseline, 4 week, 8 weeks and 12 weeks ]
    changes of gut microbiota by metagenomics


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: baseline, 4 week, 8 week and 12 weeks ]
    changes of blood pressure

  2. pulse wave velocity [ Time Frame: baseline and after 12-week intervention ]
    changes of pulse wave velocity by VP-1000plus from Omron

  3. ankle Brachial Index [ Time Frame: baseline and after 12-week intervention ]
    changes of ankle Brachial Index by VP-1000plus from Omron

  4. microbial metabolite [ Time Frame: baseline and after 12-week intervention ]
    changes of microbial metabolite by untargeted metabolomics


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible subjects include men and women 18 to 75 years of age with primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/L or higher and/ or an LDL cholesterol level of 2.59 mmol/L or higher;
  • Absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics.

Exclusion Criteria:

  • Triglyceride levels higher than 3.95 mmol/L, or any other systemic, metabolic and cardiovascular or cerebrovascular diseases;
  • Type 1 diabetes, type 2 diabetes treated with insulin or other medications;
  • Acute illness or current evidence of acute or chronic inflammatory or infective diseases;
  • Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment;
  • Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
Contacts and Locations

Contacts
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Contact: Min Xia, PhD +86 20 87332433 xiamin@mail.sysu.edu.cn
Contact: Yongxin Ye, MBBS +86 18820791517 931782413@qq.com

Locations
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China, Guangdong
Department of Nutrition and Food Hygiene Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Min Xia, PhD    +86 20 87332433    xiamin@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Min Xia, PhD Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE May 12, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE May 12, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Total cholesterol [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of total cholesterol levels in plasma by automatic biochemical analyzer
  • LDL-cholesterol [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer
  • Triglyceride [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of triglyceride levels in plasma by automatic biochemical analyzer
  • non HDL-cholesterol [ Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks ]
    changes of non HDL-cholesterol levels in plasma
  • gut microbiota [ Time Frame: baseline, 4 week, 8 weeks and 12 weeks ]
    changes of gut microbiota by metagenomics
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • blood pressure [ Time Frame: baseline, 4 week, 8 week and 12 weeks ]
    changes of blood pressure
  • pulse wave velocity [ Time Frame: baseline and after 12-week intervention ]
    changes of pulse wave velocity by VP-1000plus from Omron
  • ankle Brachial Index [ Time Frame: baseline and after 12-week intervention ]
    changes of ankle Brachial Index by VP-1000plus from Omron
  • microbial metabolite [ Time Frame: baseline and after 12-week intervention ]
    changes of microbial metabolite by untargeted metabolomics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Probiotics on Lipid Management
Official Title  ICMJE Role of Probiotics in the Management of Hypercholesterolemia
Brief Summary Dysbiosis of gut microbiota has been reported to be involved in the development of hypercholesterolemia in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate dyslipidemia in adults remain obscure.
Detailed Description Probiotics are live microorganisms that have been associated with multiple health benefits. However, its protective role in adults has long been controversial. This study aims to examine the effect of 12-week probiotics supplementation on lipid management in Chinese adults. By understanding the mechanism by which probiotics exert the beneficial effects, we can better control the rising prevalence of hypercholesterolemia, which is a major risk factor for cardiovascular diseases.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
placebo-controlled, randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
Primary Purpose: Prevention
Condition  ICMJE Primary Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Lactobacillus paracasei dietary supplement
    a commercial probiotic dietary supplement
  • Other: Placebo controls
    placebo with a similar appearance to probiotics supplement
Study Arms  ICMJE
  • Experimental: Probiotics group
    Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.
    Intervention: Dietary Supplement: Lactobacillus paracasei dietary supplement
  • Placebo Comparator: Placebo group
    Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.
    Intervention: Other: Placebo controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eligible subjects include men and women 18 to 75 years of age with primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/L or higher and/ or an LDL cholesterol level of 2.59 mmol/L or higher;
  • Absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics.

Exclusion Criteria:

  • Triglyceride levels higher than 3.95 mmol/L, or any other systemic, metabolic and cardiovascular or cerebrovascular diseases;
  • Type 1 diabetes, type 2 diabetes treated with insulin or other medications;
  • Acute illness or current evidence of acute or chronic inflammatory or infective diseases;
  • Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment;
  • Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952169
Other Study ID Numbers  ICMJE ProHealth-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Min Xia, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Min Xia, PhD Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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