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)

NCT07559110 | Not Yet Recruiting

• 1 other identifier: SALICOL
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia

Keywords

food supplement; polyphenol; Dyslipidaemia

Outcome Measures

Primary Outcomes (8)

• Total cholesterol (g/dL)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

  Baseline and 3 months

Secondary Outcomes (7)

• Sodium (mEq/L)

  Baseline and 3 months

• Potassium (mEq/L)

  Baseline and 3 months

• Homocysteine (µmol/L)

  Baseline and 3 months

• Count of returned treatment capsules.

  3 months

• Severity of the adverse event

  3 months

Study Arms (2)

Treatment

EXPERIMENTAL

Food supplement to be taken once a day.

Dietary Supplement: Halophyte plant extracts

Clinical practice

NO INTERVENTION

Without intervention

Interventions

Halophyte plant extracts DIETARY_SUPPLEMENT

Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.

Treatment

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joan Montaner Villalonga: collaborator
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

University Hospital Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Soledad Pérez Sánchez

  Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

University Hospital Virgen Macarena

CONTACT

+34608114878; neurovascular.macarena@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)