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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)

23. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Behandling
Kosttilskud, der skal indtages en gang om dagen.
Kosttilskud: Halophyte plant extracts
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.
Ingen indgriben: Klinisk praksis
Uden indgriben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total cholesterol (g/dL)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sodium (mEq/L)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 3 months
Confirm adequate adherence to dietary supplementation.
3 months
Severity of the adverse event
Tidsramme: 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)
Tidsramme: Baseline and 3 months.
Baseline and 3 months.
Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time
Tidsramme: 3 months
<1 low-risk; >=1 to <5 moderat- risk; >=5 to <10 high-risk; >=10 very-high-risk
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Samarbejdspartnere

Joan Montaner Villalonga

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2026

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SALICOL

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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