Cardiovascular DiseasesPhase 1NCT04029818
Evaluation of a Probiotic on LDL-cholesterol Levels
A Phase 1 study testing Bifidobacterium BSL_PS404 in people with Cardiovascular Diseases and LDL-cholesterol, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, LDL-cholesterol
- What is being tested?
- Bifidobacterium BSL_PS404
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 24 May 2019to 31 Jul 2019
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Levels of LDL-cholesterol between 100 and 190 mg/dL.
- Accept freely to participate in the study and sign the informed consent document.
Who cannot join
- Be pregnant.
- Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
- Having a serious illness.
- Having diabetes.
- Having a cerebrovascular disease.
- Being allergic to any group of antibiotics.
Show all 9Show fewer
- Take probiotics in the form of supplements at least 4 weeks before.
- Take antibiotics at least 4 weeks before.
- Being taking products or drugs to control cholesterol levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers
The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals.
Read the detailed description
There is a strong correlation between LDL-cholesterol and cardiovascular diseases.
Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.
Several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.
- Conditions
- Cardiovascular Diseases, LDL-cholesterol
- Being tested
- Bifidobacterium BSL_PS404, Placebo
- Keywords
- LDL-cholesterol, Probiotics
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium BSL_PS404Biological
Each participant will consume 1 capsule daily at lunch for 8 weeks.
PlaceboBiological
Each participant will consume 1 capsule daily at lunch for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Volunteers will take a capsule with Bifidobacterium BSL_PS404 (3x109 cfu) daily. Receives: Biological: Bifidobacterium BSL_PS404 |
| Placebo | Placebo comparator | Volunteers will take a capsule with maltodextrin daily. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol
Levels of LDL-cholesterol in plasma
Measured: 8 weeks
Secondary outcomes (6)
Total cholesterol
Levels of total cholesterol in plasma
Measured: 8 weeks
HDL-cholesterol
Levels of HDL-cholesterol in plasma
Measured: 8 weeks
Triglycerides
Levels of triglycerides in plasma
Measured: 8 weeks
Glucose
Levels of glucose in plasma
Measured: 8 weeks
Blood pressure
Systolic and diastolic pressure
Measured: 8 weeks
Body mass index
A person's weight in kilograms (kg) divided by his or her height in meters squared
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start24 May 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miguel Quesada, MD, PhD, Study chair, Medical specialist in Endocrinology, Hospital San Cecilio de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029818
- Sponsor's protocol ID
- P046
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 15 Nov 2019
- 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 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04029818
- Acronym / sponsor ID
- P046
- Conditions
- Cardiovascular Diseases, LDL-cholesterol
- Keywords
- LDL-cholesterol, Probiotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 24 May 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 23 Jul 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.
The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals.
Detailed description
There is a strong correlation between LDL-cholesterol and cardiovascular diseases.
Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.
Several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Biological: Bifidobacterium BSL_PS404Volunteers will take a capsule with Bifidobacterium BSL_PS404 (3x109 cfu) daily. |
| Placebo | Placebo comparator | Biological: PlaceboVolunteers will take a capsule with maltodextrin daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Levels of LDL-cholesterol between 100 and 190 mg/dL.
- Accept freely to participate in the study and sign the informed consent document.
Key exclusion criteria (9 listed)
- Be pregnant.
- Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
- Having a serious illness.
- Having diabetes.
- Having a cerebrovascular disease.
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 |
|---|---|---|
| Bifidobacterium BSL_PS404Each participant will consume 1 capsule daily at lunch for 8 weeks. | Biological | Probiotic |
| PlaceboEach participant will consume 1 capsule daily at lunch for 8 weeks. | Biological | Placebo |
Primary outcome
LDL-cholesterol
Time frame: 8 weeks
Levels of LDL-cholesterol in plasma
6 secondary outcomes
Total cholesterol
Time frame: 8 weeks
HDL-cholesterol
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Body mass index
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- 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.
Miguel Quesada, MD, PhD study chair
Medical specialist in Endocrinology, Hospital San Cecilio de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bifidobacterium BSL_PS404 in people with Cardiovascular Diseases and LDL-cholesterol, run by Biosearch S.A. at 1 site in Spain.
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 9 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: finished, as of the sponsor's last update on 15 Nov 2019. 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 Spain. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LDL-cholesterol (time frame: 8 weeks). 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 15 Nov 2019.