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.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Total cholesterol (g/dL)
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment
Food supplement to be taken once a day.
干预措施: Halophyte plant extracts (Dietary Supplement)
Clinical practice
Without intervention
结局指标
主要结局
Total cholesterol (g/dL)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: Baseline and 3 months
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
次要结局
- Sodium (mEq/L)(Baseline and 3 months)
- Potassium (mEq/L)(Baseline and 3 months)
- Homocysteine (µmol/L)(Baseline and 3 months)
- Count of returned treatment capsules.(3 months)
- Severity of the adverse event(3 months)
- Blood pressure (mmHg)(Baseline and 3 months.)
- Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time(3 months)