Clinical Trials in Spain / NCT07559110
Starting soon
Not applicable
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)
NCT07559110 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Dyslipidemia
Investigational drug(s) / intervention(s)
Halophyte plant extracts
Halophyte plant extracts: Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.
Study summary
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
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.
Primary outcome measure(s)
- Total cholesterol (g/dL) — Baseline and 3 months
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) — Baseline and 3 months
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) — Baseline and 3 months
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) — Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. - Triglycerides (mg/dL) — Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. - Remnant cholesterol (mg/dL) — Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. - Apolipoprotein B (mg/dL) — Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. - Lipoprotein (a) (mg/dL) — Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Virgen Macarena | Seville | Spain |
More Fundación Pública Andaluza para la gestión de la Investigación en Sevilla trials in Spain
Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia
Active, not recruiting
Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
Starting soon
Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia
Active, not recruiting
A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)
Starting soon
Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07559110 on ClinicalTrials.gov ↗ ← All trials in Spain