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| Name | Class |
|---|---|
| Joan Montaner Villalonga | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Food supplement to be taken once a day. |
|
| Clinical practice | No Intervention | Without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol (g/dL) | Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. | 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. | 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. | 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. | 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. | 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. | Baseline and 3 months |
| Apolipoprotein B (mg/dL) |
| Measure | Description | Time Frame |
|---|---|---|
| Sodium (mEq/L) | Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. | Baseline and 3 months |
| Potassium (mEq/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| University Hospital Virgen Macarena | Contact | +34608114878 | neurovascular.macarena@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Soledad Pérez Sánchez | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Virgen Macarena | Seville | 41009 | Spain |
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).
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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.
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Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
| Baseline and 3 months |
| Lipoprotein (a) (mg/dL) | Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. | Baseline and 3 months |
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
| 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. | Baseline and 3 months |
| Count of returned treatment capsules. | Confirm adequate adherence to dietary supplementation. | 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. | 3 months |
| Blood pressure (mmHg) | 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 | 3 months |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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