Dyslipidemia
Conditions
Keywords
food supplement, polyphenol, Dyslipidaemia
Brief 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.
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_SUPPLEMENTHalophyte plant extracts
Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Joan Montaner Villalonga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sodium (mEq/L) | Baseline and 3 months | Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. |
| Potassium (mEq/L) | Baseline and 3 months | Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. |
| Homocysteine (µmol/L) | Baseline and 3 months | Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice. |
| Count of returned treatment capsules. | 3 months | Confirm adequate adherence to dietary supplementation. |
| Severity of the adverse event | 3 months | \- 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. |
| Blood pressure (mmHg) | Baseline and 3 months. | — |
| Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time | 3 months | \<1 low-risk; \>=1 to \<5 moderat- risk; \>=5 to \<10 high-risk; \>=10 very-high-risk |
Countries
Spain
Contacts
CONTACTUniversity Hospital Virgen Macarena
PRINCIPAL_INVESTIGATORSoledad Pérez Sánchez
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Outcome results
None listed