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)

ConditionDyslipidemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: Clinical practiceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

Count of returned treatment capsules.

Confirm adequate adherence to dietary supplementation.

Time frame
3 months

Other outcomes

Sponsors and contacts

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