DyslipidemiaSALICOLNCT07559110
Supplementation With Salicornia Extract Rich in Polyphenols (B-Salicornia) to Improve Vascular Health in Patients With Dyslipidemia Who Are Not Candidates for Drug Treatment (Low to Moderate Risk)
A study testing Halophyte plant extracts in people with Dyslipidemia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The aim of this clinical trial is to evaluate the ability of a dietary supplement based on salicornia extracts and B vitamins (B-Salicornia) to modulate lipid levels in a population with newly diagnosed dyslipidemia who are not eligible for medical treatment. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Halophyte plant extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 40 to 65
- Newly diagnosed dyslipidemia (two years) with SCORE ≥1 - <5 (LDL 116 - <190 mg/dL): Moderate Risk
- No indication for pharmacological treatment in primary prevention.
- Possibility of performing analytical controls at the beginning/end of the study.
- Willingness and capacity to give informed consent.
Who cannot join
- Participants with vascular risk requiring pharmacological treatment or high/very high vascular risk.
- Participants in secondary prevention.
- Hyperthyroidism according to the researcher's criteria.
- Taking vitamin B supplements and/or supplements containing polyphenols in the 30 days prior to the screening visit (at the researcher's discretion).
- Serious illness with a life expectancy of less than three months.
- Known allergies or intolerance to halophytic plants.
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- Pregnant or breastfeeding women.
- Presence of active neoplastic disease.
- Having participated in another clinical trial with medicines in the 30 days prior to the screening visit, or intending to do so during your participation in this study.
- Regular consumption of halophyte plants.
- Participants who, in the researcher's opinion, are not able to comply with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
University Hospital Virgen Macarena
Seville, 41009
Soledad Pérez Sánchez, +34608114878, neurovascular.macarena@gmail.com
About this study
Official title: Prospective, Randomized, Open-label, Parallel-Group Pilot Study Compared With Usual Medical Practice and Blinded Analysis (PROBE), to Evaluate the Effect and Safety of Administering a Food Supplement Based on Halophyte Plant Extracts in Patients With Newly Diagnosed Dyslipidemia Who do Not Have an Indication for Medical Treatment.
The aim of this clinical trial is to evaluate the ability of a dietary supplement based on salicornia extracts and B vitamins (B-Salicornia) to modulate lipid levels in a population with newly diagnosed dyslipidemia who are not eligible for medical treatment.
Read the detailed description
Researchers will compare the treatment group taking the B-Salicornia supplement plus standard medical treatment with a control group receiving standard medical treatment.
Participants will:
- Take 500 mg of the B-Salicornia dietary supplement daily for three months.
- Visit the hospital at the beginning and end of the trial for a physical examination and routine blood tests, including vascular parameters such as lipids and homocysteine.
- Conditions
- Dyslipidemia
- Being tested
- Halophyte plant extracts
- Keywords
- food supplement, polyphenol, Dyslipidaemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halophyte plant extractsDietary supplement
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Food supplement to be taken once a day. Receives: Dietary Supplement: Halophyte plant extracts |
| Clinical practice | No intervention | Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol (g/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Low Density Lipoprotein cholesterol (mg/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Oxidation of Low Density Lipoprotein cholesterol (mg/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
High-Density Lipoprotein cholesterol (mg/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Triglycerides (mg/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Remnant cholesterol (mg/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Apolipoprotein B (mg/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Lipoprotein (a) (mg/dL)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Secondary outcomes (7)
Sodium (mEq/L)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Potassium (mEq/L)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Homocysteine (µmol/L)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Measured: Baseline and 3 months
Count of returned treatment capsules.
Confirm adequate adherence to dietary supplementation.
Measured: 3 months
Severity of the adverse event
- Mild: No antidote or treatment required; brief hospitalisation. - MODERATE: Treatment modification required (e.g., dose change, addition of another drug), but discontinuation of the drug is not essential; prolonged administration of the drug is not essential; prolonged hospitalisation or treatment may be necessary, or specific hospitalisation or treatment may be necessary. - SEVERE: The adverse drug reaction is life-threatening and requires discontinuation of the drug. Drug administration should be discontinued and specific treatment instituted. - FATAL: An adverse drug reaction may directly or indirectly contribute to the death of the patient.
Measured: 3 months
Blood pressure (mmHg)
Measured: Baseline and 3 months.
Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time
<1 low-risk; >=1 to <5 moderat- risk; >=5 to <10 high-risk; >=10 very-high-risk
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Model description
- Prospective, randomized, open-label, parallel-group pilot study compared with usual medical practice and blinded analysis (PROBE) to evaluate the effect and safety of administering a food supplement based on halophyte plant extracts in patients with newly diagnosed dyslipidemia who do not have an indication for medical treatment.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Joan Montaner Villalonga
- Responsible party
- Sponsor
- Investigators
- Soledad Pérez Sánchez, Principal investigator, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559110
- Sponsor's protocol ID
- SALICOL
- Acronym
- SALICOL
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The personal data collected in this study will be treated confidentially by the center and sponsor of the study (Public Foundation for Research in Seville - FISEVI). The Principal Investigator may grant access to and make this data available to members of the project team. The personal data collected in carrying out this study will be subject to personal data processing, always respecting the provisions of the General Data Protection Regulation of the European Union (GDPR) and Organic Law 3/2018, of December 5, on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD).
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open-label, Parallel-Group Pilot Study Compared With Usual Medical Practice and Blinded Analysis (PROBE), to Evaluate the Effect and Safety of Administering a Food Supplement Based on Halophyte Plant Extracts in Patients With Newly Diagnosed Dyslipidemia Who do Not Have an Indication for Medical Treatment.
- ClinicalTrials.gov ID
- NCT07559110
- Acronym / sponsor ID
- SALICOL / SALICOL
- Conditions
- Dyslipidemia
- Keywords
- food supplement, polyphenol, Dyslipidaemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Joan Montaner Villalonga
- Study start
- May 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Apr 2026 (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 this clinical trial is to evaluate the ability of a dietary supplement based on salicornia extracts and B vitamins (B-Salicornia) to modulate lipid levels in a population with newly diagnosed dyslipidemia who are not eligible for medical treatment.
Detailed description
Researchers will compare the treatment group taking the B-Salicornia supplement plus standard medical treatment with a control group receiving standard medical treatment.
Participants will:
- Take 500 mg of the B-Salicornia dietary supplement daily for three months.
- Visit the hospital at the beginning and end of the trial for a physical examination and routine blood tests, including vascular parameters such as lipids and homocysteine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label, parallel-group pilot study compared with usual medical practice and blinded analysis (PROBE) to evaluate the effect and safety of administering a food supplement based on halophyte plant extracts in patients with newly diagnosed dyslipidemia who do not have an indication for medical treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Halophyte plant extractsFood supplement to be taken once a day. |
| Clinical practice | No intervention | –Without intervention |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants aged 40 to 65
- Newly diagnosed dyslipidemia (two years) with SCORE ≥1 - <5 (LDL 116 - <190 mg/dL): Moderate Risk
- No indication for pharmacological treatment in primary prevention.
- Possibility of performing analytical controls at the beginning/end of the study.
- Willingness and capacity to give informed consent.
Key exclusion criteria (11 listed)
- Participants with vascular risk requiring pharmacological treatment or high/very high vascular risk.
- Participants in secondary prevention.
- Hyperthyroidism according to the researcher's criteria.
- Taking vitamin B supplements and/or supplements containing polyphenols in the 30 days prior to the screening visit (at the researcher's discretion).
- Serious illness with a life expectancy of less than three months.
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 |
|---|---|---|
| Halophyte plant extractsDietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months. | Dietary supplement | Treatment |
Primary outcome
Total cholesterol (g/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Low Density Lipoprotein cholesterol (mg/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Oxidation of Low Density Lipoprotein cholesterol (mg/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
High-Density Lipoprotein cholesterol (mg/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Triglycerides (mg/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Remnant cholesterol (mg/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Apolipoprotein B (mg/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Lipoprotein (a) (mg/dL)
Time frame: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
7 secondary outcomes
Sodium (mEq/L)
Time frame: Baseline and 3 months
Potassium (mEq/L)
Time frame: Baseline and 3 months
Homocysteine (µmol/L)
Time frame: Baseline and 3 months
Count of returned treatment capsules.
Time frame: 3 months
Severity of the adverse event
Time frame: 3 months
Blood pressure (mmHg)
Time frame: Baseline and 3 months.
Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. The personal data collected in this study will be treated confidentially by the center and sponsor of the study (Public Foundation for Research in Seville - FISEVI). The Principal Investigator may grant access to and make this data available to members of the project team. The personal data collected in carrying out this study will be subject to personal data processing, always respecting the provisions of the General Data Protection Regulation of the European Union (GDPR) and Organic Law 3/2018, of December 5, on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD).
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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.
Soledad Pérez Sánchez principal investigator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Halophyte plant extracts in people with Dyslipidemia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 Apr 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact University Hospital Virgen Macarena (+34608114878, neurovascular.macarena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (g/dL) (time frame: Baseline and 3 months). The study lists 8 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 30 Apr 2026.