Back to resultsEffect of Probiotics on Lipid Management
Primary Purpose
Primary Hypercholesterolemia
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lactobacillus paracasei dietary supplement
Placebo controls
Sponsored by
About this trial
This is an interventional prevention trial for Primary Hypercholesterolemia focused on measuring Primary Hypercholesterolemia, Probiotics, Cardiovascular risk
Eligibility 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.
Sites / Locations
- Department of Nutrition and Food Hygiene
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotics group
Placebo group
Arm Description
Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Outcomes
Primary Outcome Measures
Total cholesterol
changes of total cholesterol levels in plasma by automatic biochemical analyzer
LDL-cholesterol
changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer
Triglyceride
changes of triglyceride levels in plasma by automatic biochemical analyzer
non HDL-cholesterol
changes of non HDL-cholesterol levels in plasma
gut microbiota
changes of gut microbiota by metagenomics
Secondary Outcome Measures
blood pressure
changes of blood pressure
pulse wave velocity
changes of pulse wave velocity by VP-1000plus from Omron
ankle Brachial Index
changes of ankle Brachial Index by VP-1000plus from Omron
microbial metabolite
changes of microbial metabolite by untargeted metabolomics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03952169
Brief Title
Effect of Probiotics on Lipid Management
Official Title
Role of Probiotics in the Management of Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
Keywords
Primary Hypercholesterolemia, Probiotics, Cardiovascular risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
placebo-controlled, randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics group
Arm Type
Experimental
Arm Description
Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus paracasei dietary supplement
Intervention Description
a commercial probiotic dietary supplement
Intervention Type
Other
Intervention Name(s)
Placebo controls
Intervention Description
placebo with a similar appearance to probiotics supplement
Primary Outcome Measure Information:
Title
Total cholesterol
Description
changes of total cholesterol levels in plasma by automatic biochemical analyzer
Time Frame
baseline, 4 weeks, 8 weeks and 12 weeks
Title
LDL-cholesterol
Description
changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer
Time Frame
baseline, 4 weeks, 8 weeks and 12 weeks
Title
Triglyceride
Description
changes of triglyceride levels in plasma by automatic biochemical analyzer
Time Frame
baseline, 4 weeks, 8 weeks and 12 weeks
Title
non HDL-cholesterol
Description
changes of non HDL-cholesterol levels in plasma
Time Frame
baseline, 4 weeks, 8 weeks and 12 weeks
Title
gut microbiota
Description
changes of gut microbiota by metagenomics
Time Frame
baseline, 4 week, 8 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Description
changes of blood pressure
Time Frame
baseline, 4 week, 8 week and 12 weeks
Title
pulse wave velocity
Description
changes of pulse wave velocity by VP-1000plus from Omron
Time Frame
baseline and after 12-week intervention
Title
ankle Brachial Index
Description
changes of ankle Brachial Index by VP-1000plus from Omron
Time Frame
baseline and after 12-week intervention
Title
microbial metabolite
Description
changes of microbial metabolite by untargeted metabolomics
Time Frame
baseline and after 12-week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Xia, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition and Food Hygiene
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Probiotics on Lipid Management
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