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) (SALICOL)

April 23, 2026 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Food supplement to be taken once a day.
Dietary supplement: Halophyte plant extracts
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.
No Intervention: Clinical practice
Without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sodium (mEq/L)
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.
Baseline and 3 months
Potassium (mEq/L)
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.
Baseline and 3 months
Homocysteine (µmol/L)
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.
Baseline and 3 months
Count of returned treatment capsules.
Time Frame: 3 months
Confirm adequate adherence to dietary supplementation.
3 months
Severity of the adverse event
Time Frame: 3 months
- 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.
3 months
Blood pressure (mmHg)
Time Frame: Baseline and 3 months.
Baseline and 3 months.
Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time
Time Frame: 3 months
<1 low-risk; >=1 to <5 moderat- risk; >=5 to <10 high-risk; >=10 very-high-risk
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Joan Montaner Villalonga

Investigators

  • Principal Investigator: Soledad Pérez Sánchez, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALICOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on Halophyte plant extracts

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe