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 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: University Hospital Virgen Macarena
- Telefonnummer: +34608114878
- E-post: neurovascular.macarena@gmail.com
Studiesteder
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Seville, Spania, 41009
- University Hospital Virgen Macarena
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Ta kontakt med:
- Soledad Pérez Sánchez
- Telefonnummer: +34608114878
- E-post: neurovascular.macarena@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Behandling
Kosttilskudd som skal tas én gang om dagen.
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Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment.
Dosage: once daily.
Duration of study: 3 months.
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Ingen inngripen: Klinisk praksis
Uten intervensjon
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total cholesterol (g/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Low Density Lipoprotein cholesterol (mg/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Oxidation of Low Density Lipoprotein cholesterol (mg/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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High-Density Lipoprotein cholesterol (mg/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Triglycerides (mg/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Remnant cholesterol (mg/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Apolipoprotein B (mg/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Lipoprotein (a) (mg/dL)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sodium (mEq/L)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Potassium (mEq/L)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Homocysteine (µmol/L)
Tidsramme: Baseline and 3 months
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
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Count of returned treatment capsules.
Tidsramme: 3 months
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Confirm adequate adherence to dietary supplementation.
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3 months
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Severity of the adverse event
Tidsramme: 3 months
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- 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.
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3 months
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Blood pressure (mmHg)
Tidsramme: Baseline and 3 months.
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Baseline and 3 months.
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Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time
Tidsramme: 3 months
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<1 low-risk; >=1 to <5 moderat- risk; >=5 to <10 high-risk; >=10 very-high-risk
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3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Soledad Pérez Sánchez, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. mai 2026
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
23. april 2026
Først innsendt som oppfylte QC-kriteriene
23. april 2026
Først lagt ut (Faktiske)
30. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. april 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SALICOL
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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).
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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