Cardiovascular DiseaseNCT04029727
Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health
A study testing Combination of Plant Extracts (BSL_EP025) in people with Cardiovascular Disease, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The objective of the study is to evaluate the ability of a combination of plant extracts (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in individuals with LDL-cholesterol levels between 100 and 190 mg/dL. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Combination of Plant Extracts (BSL_EP025)
- 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
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women between 18 and 65 years of age.
- 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.
- Suffer from a serious illness.
- Have diabetes.
- Having a cerebrovascular disease.
- Be taking products or drugs to control cholesterol levels or with antioxidant activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Effect of the Consumption of a Combination of Plant Extracts (BSL_EP025) on the Levels of LDL-cholesterol and Oxidized LDL-cholesterol in Healthy Volunteers
The objective of the study is to evaluate the ability of a combination of plant extracts (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
Read the detailed description
There is a strong relationship between serum cholesterol levels and cardiovascular diseases, especially between coronary artery disease and LDL-cholesterol (LDL).
LDL is the lipoprotein responsible for delivering cholesterol to cells. However, in recent years, special attention has been given to modified LDL, especially oxidized LDL, since it plays a very important role in the initiation and progression of the atheroma plaque.
There are environmental and genetic factors that can influence the type and levels of blood lipoproteins. Among the modulable factors (environmental) it has been observed that some phytochemical compounds found in several plant extracts may reduce cardiovascular risk, due to their antioxidant and anti-inflammatory properties.
The objective of the present study is to evaluate the possible effect of the intake of a combination of plant extracts (BSL_EP025) on the levels of LDL-cholesterol and oxidized LDL-cholesterol in healthy individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
- Conditions
- Cardiovascular Disease
- Being tested
- Combination of Plant Extracts (BSL_EP025), Placebo
- Keywords
- Plant extract, LDL cholesterol, Dietary supplement
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Plant Extracts (BSL_EP025)Dietary supplement
Each participant will consume 2 capsules daily at lunch for 8 weeks.
PlaceboDietary supplement
Each participant will consume 2 capsules daily at lunch for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Plant Extracts (BSL_EP025) | Experimental | The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP025) Receives: Dietary Supplement: Combination of Plant Extracts (BSL_EP025) |
| Placebo | Placebo comparator | The volunteers will take two capsules daily with maltodextrin. Receives: Dietary Supplement: 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
Oxidized LDL cholesterol
Levels of oxidized LDL cholesterol in plasma
Measured: 8 weeks
Secondary outcomes (11)
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 blood pressure
Measured: 8 weeks
Body mass index
Weight/height ratio
Measured: 8 weeks
VCAM-1
Plasma levels of VCAM-1
Measured: 8 weeks
ICAM-1
Plasma levels of ICAM-1
Measured: 8 weeks
Beta IL-1
Plasma levels of beta IL-1
Measured: 8 weeks
IL-6
Plasma levels of IL-6
Measured: 8 weeks
IL-10
Plasma levels of IL-10
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 DiseaseStudies 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 N/A
- 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
- NCT04029727
- Sponsor's protocol ID
- C025
- 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
- Pilot Study to Evaluate the Effect of the Consumption of a Combination of Plant Extracts (BSL_EP025) on the Levels of LDL-cholesterol and Oxidized LDL-cholesterol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04029727
- Acronym / sponsor ID
- C025
- Conditions
- Cardiovascular Disease
- Keywords
- Plant extract, LDL cholesterol, Dietary supplement
- 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 objective of the study is to evaluate the ability of a combination of plant extracts (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
Detailed description
There is a strong relationship between serum cholesterol levels and cardiovascular diseases, especially between coronary artery disease and LDL-cholesterol (LDL).
LDL is the lipoprotein responsible for delivering cholesterol to cells. However, in recent years, special attention has been given to modified LDL, especially oxidized LDL, since it plays a very important role in the initiation and progression of the atheroma plaque.
There are environmental and genetic factors that can influence the type and levels of blood lipoproteins. Among the modulable factors (environmental) it has been observed that some phytochemical compounds found in several plant extracts may reduce cardiovascular risk, due to their antioxidant and anti-inflammatory properties.
The objective of the present study is to evaluate the possible effect of the intake of a combination of plant extracts (BSL_EP025) on the levels of LDL-cholesterol and oxidized LDL-cholesterol in healthy individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
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 |
|---|---|---|
| Combination of Plant Extracts (BSL_EP025) | Experimental | Dietary Supplement: Combination of Plant Extracts (BSL_EP025)The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP025) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe volunteers will take two capsules daily with maltodextrin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women between 18 and 65 years of age.
- 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 (6 listed)
- Be pregnant.
- Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
- Suffer from a serious illness.
- Have 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 |
|---|---|---|
| Combination of Plant Extracts (BSL_EP025)Each participant will consume 2 capsules daily at lunch for 8 weeks. | Dietary supplement | Combination of Plant Extracts (BSL_EP025) |
| PlaceboEach participant will consume 2 capsules daily at lunch for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
LDL cholesterol
Time frame: 8 weeks
Levels of LDL cholesterol in plasma
Oxidized LDL cholesterol
Time frame: 8 weeks
Levels of oxidized LDL cholesterol in plasma
11 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
VCAM-1
Time frame: 8 weeks
ICAM-1
Time frame: 8 weeks
Beta IL-1
Time frame: 8 weeks
IL-6
Time frame: 8 weeks
IL-10
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 study testing Combination of Plant Extracts (BSL_EP025) in people with Cardiovascular Disease, 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 3 inclusion and 6 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.
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). The study lists 2 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 15 Nov 2019.