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)

N/ANot Yet RecruitingNCT07559110

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla250 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

250

Conditions

Dyslipidemia

Interventions

Halophyte plant extractsDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Virgen Macarena

Seville, Spain

Outcomes

Primary Outcomes

Total cholesterol (g/dL)

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 3 months

Central Contacts

University Hospital Virgen Macarena

CONTACT

+34608114878 neurovascular.macarena@gmail.com

Data from ClinicalTrials.gov

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Secondary Outcomes

Sodium (mEq/L)

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

Time frame: Baseline and 3 months

Potassium (mEq/L)

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

Time frame: Baseline and 3 months

Homocysteine (µmol/L)

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

Time frame: Baseline and 3 months

Count of returned treatment capsules.

Confirm adequate adherence to dietary supplementation.

Time frame: 3 months

Severity of the adverse event

\- 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.

Time frame: 3 months

Blood pressure (mmHg)

Time frame: Baseline and 3 months.

Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time

\<1 low-risk; \>=1 to \<5 moderat- risk; \>=5 to \<10 high-risk; \>=10 very-high-risk

Time frame: 3 months