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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Halophyte plant extracts.
- Who it may be relevant to
- Registry conditions: Dyslipidemia. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Halophyte plant extracts
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.
Primary outcome measures
- Total cholesterol (g/dL) [Time frame: Baseline and 3 months]
- Low Density Lipoprotein cholesterol (mg/dL) [Time frame: Baseline and 3 months]
- Oxidation of Low Density Lipoprotein cholesterol (mg/dL) [Time frame: Baseline and 3 months]
- High-Density Lipoprotein cholesterol (mg/dL) [Time frame: Baseline and 3 months]
- Triglycerides (mg/dL) [Time frame: Baseline and 3 months]
- Remnant cholesterol (mg/dL) [Time frame: Baseline and 3 months]
- Apolipoprotein B (mg/dL) [Time frame: Baseline and 3 months]
- Lipoprotein (a) (mg/dL) [Time frame: Baseline and 3 months]
Secondary outcome measures (7)
- Sodium (mEq/L) [Time frame: Baseline and 3 months]
- Potassium (mEq/L) [Time frame: Baseline and 3 months]
- Homocysteine (µmol/L) [Time frame: Baseline and 3 months]
- Count of returned treatment capsules. [Time frame: 3 months]
- Severity of the adverse event [Time frame: 3 months]
- Blood pressure (mmHg) [Time frame: Baseline and 3 months.]
- Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- University Hospital Virgen Macarena — Seville
Identifiers
NCT: NCT07559110 · SALICOL