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) (SALICOL)
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
250
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：University Hospital Virgen Macarena
- 电话号码：+34608114878
- 邮箱：neurovascular.macarena@gmail.com
学习地点
-
-
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Seville、西班牙、41009
- University Hospital Virgen Macarena
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接触：
- Soledad Pérez Sánchez
- 电话号码：+34608114878
- 邮箱：neurovascular.macarena@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：治疗
每日服用一次的食品补充剂。
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Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment.
Dosage: once daily.
Duration of study: 3 months.
|
|
无干预：临床实践
未经干预
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total cholesterol (g/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
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Low Density Lipoprotein cholesterol (mg/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
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Oxidation of Low Density Lipoprotein cholesterol (mg/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
|
High-Density Lipoprotein cholesterol (mg/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
|
Triglycerides (mg/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
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Remnant cholesterol (mg/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
|
Apolipoprotein B (mg/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
|
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Lipoprotein (a) (mg/dL)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sodium (mEq/L)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
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Baseline and 3 months
|
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Potassium (mEq/L)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
|
Homocysteine (µmol/L)
大体时间：Baseline and 3 months
|
Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.
|
Baseline and 3 months
|
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Count of returned treatment capsules.
大体时间：3 months
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Confirm adequate adherence to dietary supplementation.
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3 months
|
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Severity of the adverse event
大体时间：3 months
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- 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.
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3 months
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Blood pressure (mmHg)
大体时间：Baseline and 3 months.
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Baseline and 3 months.
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Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time
大体时间：3 months
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<1 low-risk; >=1 to <5 moderat- risk; >=5 to <10 high-risk; >=10 very-high-risk
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3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Soledad Pérez Sánchez、Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月1日
初级完成 (估计的)
2026年5月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年4月23日
首先提交符合 QC 标准的
2026年4月23日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月23日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
The personal data collected in this study will be treated confidentially by the center and sponsor of the study (Public Foundation for Research in Seville - FISEVI). The Principal Investigator may grant access to and make this data available to members of the project team.
The personal data collected in carrying out this study will be subject to personal data processing, always respecting the provisions of the General Data Protection Regulation of the European Union (GDPR) and Organic Law 3/2018, of December 5, on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD).
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.