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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Halophyte plant extracts
Dietary supplementDietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.
Treatment groups
Trial 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.
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.
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.
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.
Secondary outcomes
Sodium (mEq/L)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Potassium (mEq/L)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Homocysteine (µmol/L)
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Count of returned treatment capsules.
Confirm adequate adherence to dietary supplementation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead sponsor
Joan Montaner Villalonga
Collaborator
This trial is not recruiting at the moment. You can still explore other options: