Primary HypercholesterolemiaNCT03952169
Effect of Probiotics on Lipid Management
A study testing Lactobacillus paracasei dietary supplement in people with Primary Hypercholesterolemia, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- Lactobacillus paracasei dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nutrition and Food Hygiene
Guangzhou, Guangdong, 510080
About this study
Official title: Role of Probiotics in the Management of Hypercholesterolemia
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.
Read the 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.
- Conditions
- Primary Hypercholesterolemia
- Being tested
- Lactobacillus paracasei dietary supplement, Placebo controls
- Keywords
- Primary Hypercholesterolemia, Probiotics, Cardiovascular risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei dietary supplementDietary supplement
a commercial probiotic dietary supplement
Placebo controlsOther
placebo with a similar appearance to probiotics supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations. Receives: Dietary Supplement: Lactobacillus paracasei dietary supplement |
| Placebo group | Placebo comparator | Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations. Receives: Other: Placebo controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
changes of total cholesterol levels in plasma by automatic biochemical analyzer
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
LDL-cholesterol
changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Triglyceride
changes of triglyceride levels in plasma by automatic biochemical analyzer
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
non HDL-cholesterol
changes of non HDL-cholesterol levels in plasma
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
gut microbiota
changes of gut microbiota by metagenomics
Measured: baseline, 4 week, 8 weeks and 12 weeks
Secondary outcomes (4)
blood pressure
changes of blood pressure
Measured: baseline, 4 week, 8 week and 12 weeks
pulse wave velocity
changes of pulse wave velocity by VP-1000plus from Omron
Measured: baseline and after 12-week intervention
ankle Brachial Index
changes of ankle Brachial Index by VP-1000plus from Omron
Measured: baseline and after 12-week intervention
microbial metabolite
changes of microbial metabolite by untargeted metabolomics
Measured: baseline and after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start12 May 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled, randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Xia, Sun Yat-sen University
- Investigators
- Min Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952169
- Sponsor's protocol ID
- ProHealth-1
- Status last verified
- May 2022
- First submitted
- 12 May 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Probiotics in the Management of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03952169
- Acronym / sponsor ID
- ProHealth-1
- Conditions
- Primary Hypercholesterolemia
- Keywords
- Primary Hypercholesterolemia, Probiotics, Cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 May 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Dietary Supplement: Lactobacillus paracasei dietary supplementParticipants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
| Placebo group | Placebo comparator | Other: Placebo controlsParticipants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus paracasei dietary supplementa commercial probiotic dietary supplement | Dietary supplement | Probiotics group |
| Placebo controlsplacebo with a similar appearance to probiotics supplement | Other | Placebo group |
Primary outcome
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
4 secondary outcomes
blood pressure
Time frame: baseline, 4 week, 8 week and 12 weeks
pulse wave velocity
Time frame: baseline and after 12-week intervention
ankle Brachial Index
Time frame: baseline and after 12-week intervention
microbial metabolite
Time frame: baseline and after 12-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus paracasei dietary supplement in people with Primary Hypercholesterolemia, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (time frame: baseline, 4 weeks, 8 weeks and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.