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 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
250
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: University Hospital Virgen Macarena
- Telefonnummer: +34608114878
- E-post: neurovascular.macarena@gmail.com
Studieorter
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-
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Seville, Spanien, 41009
- University Hospital Virgen Macarena
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Kontakt:
- Soledad Pérez Sánchez
- Telefonnummer: +34608114878
- E-post: neurovascular.macarena@gmail.com
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Behandling
Livsmedelstillskott som ska tas en gång 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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Inget ingripande: Klinisk praxis
Utan intervention
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Total cholesterol (g/dL)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline and 3 months
|
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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline and 3 months
|
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)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Sodium (mEq/L)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Soledad Pérez Sánchez, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 maj 2026
Primärt slutförande (Beräknad)
1 maj 2026
Avslutad studie (Beräknad)
1 maj 2027
Studieregistreringsdatum
Först inskickad
23 april 2026
Först inskickad som uppfyllde QC-kriterierna
23 april 2026
Första postat (Faktisk)
30 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 april 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 april 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SALICOL
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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).
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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