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)

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.

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.

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.