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Effect of Probiotics on Lipid Management

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: NCT03952169
Recruitment Status : Unknown
Verified May 2019 by Min Xia, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Min Xia, Sun Yat-sen University

Study Description
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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): NCT03952169


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
More Information
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Responsible Party: Min Xia, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03952169    
Other Study ID Numbers: ProHealth-1
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Min Xia, Sun Yat-sen University:
Primary Hypercholesterolemia
Probiotics
Cardiovascular risk
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases