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NCT Number: NCT07559110

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)

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Count of returned treatment capsules.

    Time frame: 3 months

    Confirm adequate adherence to dietary supplementation.

  5. 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.
  6. Blood pressure (mmHg)

    Time frame: Baseline and 3 months.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

University Hospital Virgen Macarena

CONTACT

[email protected]

+34608114878

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Joan Montaner Villalonga

Registry information

Official study 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.

Acronym: SALICOL

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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