Effect of Probiotics on Lipid Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-12

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo-controlled, randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Probiotics group

Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Group Type EXPERIMENTAL

Lactobacillus paracasei dietary supplement

Intervention Type DIETARY_SUPPLEMENT

a commercial probiotic dietary supplement

Placebo group

Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Group Type PLACEBO_COMPARATOR

Placebo controls

Intervention Type OTHER

placebo with a similar appearance to probiotics supplement

Interventions

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Lactobacillus paracasei dietary supplement

a commercial probiotic dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo controls

placebo with a similar appearance to probiotics supplement

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes