Halophyte Plants as a Dietary Supplement to Improve Neurovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is evaluate the effect and safety of the administration of a food supplement based on halophyte plant extracts versus placebo in the neurovascular healthy.
详细描述
After being informed about the study and giving written informed consent, healthy volunteers (substudy A), patients with transient ischemic attack (TIA) or MINOR stroke (substudy B), patients with cerebral small vessel disease (substudy C) and patients who have suffered a non-disabling stroke and are going to receive carotid angioplasty and stenting (CAS) (substudy D) will be randomized in double-blind manner (participant and investigator) to take a food supplement based on halophyte plant extracts (1 g once a day) or placebo (once a day) for a treatment period of 3 months (substudy A), 11 months (substudy B), 1 year (substudy C) or 7-30 days (substudy D). Participants in substudy A will be twice as likely to be assigned to the experimental treatment as to placebo (2:1 ratio), while those in substudies B, C and D will be equally likely (1:1 ratio).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The BIO-DIS company in Seville prepared the extract/placebo bottles for each study arm by assigning them a unique coding for each participant that does not distinguish between extract and placebo. This coding is then the participant's study code. Treatment bottles were prepared and coded according to the ratio of dietary supplement/placebo (1:1 for Branch B, C and D and 2:1 for Branch A) and the number of participants in each branch.
The list indicating which treatment (supplement/placebo) each coding corresponds to will be kept at the Hospital Universtario Virgen Macarena (HUVM) Pharmacy Service for the duration of the study. The blind will only be disclosed in the event of an adverse event (AE) that requires it and/or after completion of the analysis of the main end-points of each arm in a blinded manner.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥18 years old
- •Possibility of analytical controls at the beginning/end of the study.
- •Willingness and ability to give informed consent.
排除标准
- •Known neurovascular disease.
- •Other chronic diseases for which the subject is taking medication on a regular basis.
- •Hyperthyroidism according to the investigator's criteria.
- •Volunteers taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
- •Severe illness with life expectancy of less than three months.
- •Known allergies or intolerance to halophyte plants.
- •Pregnant or lactating women.
- •Presence of active neoplastic disease.
- •Having participated in another clinical trial with medicinal products in the 30 days prior to the screening visit, or intending to do so during their participation in this study.
- •Habitual consumption of halophyte plants.
- •Patients who, at the investigator's discretion, are not able to comply with the study protocol.
- •Substudy B:
- •Inclusion criteria:
- •Patients ≥18 years old.
- •Patients with typical symptoms lasting less than 24 hours seen at the HUVM classified as TIA or minor stroke (if Diffusion weighted imaging (DWI) positive on magnetic resonance imaging (MRI)) during the last year.
- •Have a neuroimaging performed at the time of the acute episode that rules out other non-vascular lesions.
- •Willingness and ability to give informed consent.
- •Exclusion criteria:
- •Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
- •Having participated in another clinical trial with medicinal products in the 30 days prior to the screening visit, or intending to do so during their participation in this study.
- •Hyperthyroidism at the investigator's discretion.
- •Dysphagia that prevents the intake of the study treatment.
- •Patients dependent for basic activities of daily living (mRS >3) or with severe disease with life expectancy of less than 12 months.
- •Known allergies or intolerance to halophyte plants.
- •Habitual consumption of halophyte plants.
- •Pregnant or lactating women.
- •Presence of active neoplastic disease.
- •Patients who, at the investigator's discretion, are unable to comply with the study protocol.
- •Substudy C:
- •Inclusion criteria:
- •Patients ≥18 years of age.
- •Lacunar syndrome with acute ischaemic lesion on neuroimaging of less than 1.5 cm maximum diameter.
- •Willingness and ability to give informed consent.
- •Exclusion criteria:
- •Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).
- •Hyperthyroidism at the investigator's discretion.
- •Claustrophobia or morbid obesity (IMT >40) precluding performance of MRI 3 Tesla.
- •Patients dependent for basic activities of daily living (mRS >3) or with severe disease with an expected life expectancy of less than 12 months.
- •Dysphagia that prevents the intake of the study treatment.
- •Known allergies or intolerances to halophyte plants.
- •Pregnant or breastfeeding women.
- •Presence of active neoplastic disease.
- •Having participated in another clinical trial with medicinal products in the 30 days prior to the screening visit, or intending to do so during their participation in this study.
- •Habitual consumption of halophyte plants.
- •Patients who, at the investigator's discretion, are not able to comply with the study protocol.
- •Substudy D:
- •Inclusion criteria:
- •Patient with carotid stenosis that warrants treatment in one of the following cases:
- •Symptomatic carotid stenosis >50% with stroke within 6 months prior to inclusion and not disabling at the time of inclusion.
- •Asymptomatic carotid stenosis >70% provided some of the following criteria are met:
- 另有 21 项未显示
结局指标
主要结局
Incidence of adverse events
时间窗: Through study completion, up to 1 year.
The safety and tolerability of the supplement shall be quantified in terms of the incidence of adverse events. The frequency of adverse events and the percentage of adverse events causing subject withdrawal from the study shall be determined.
次要结局
- Participants with change from baseline in blood Fatty acid-binding protein 2 (FABP2)(Baseline and up to 1 year.)
- Participants with change from baseline in blood cholesterol(Baseline and up to 1 year.)
- Participants with change from baseline in blood glycosylated haemoglobin(Baseline and up to 1 year.)
- Participants with change from baseline in blood homocysteine(Baseline and up to 1 year.)
- Changes in Functional Ambulatory Profile (FAP) (in substudies B and C)(Baseline, 6 months and 1 year.)
- Changes in average systolic blood pressure (in substudy C)(Baseline, 6 months and 1 year.)
- Changes in average diastolic blood pressure (in substudy C)(Baseline, 6 months and 1 year.)
- Efficacy in preventing new diffusion-weighted imaging (DWI) cerebral lesions from baseline (in substudy D)(Final visit (from day 7 to day 30))
- Efficacy in preventing new lesions related to small vessel disease from baseline (in substudy C).(Baseline and 1 year.)
- Efficacy in preventing new major cardiovascular events (in substudies B and C).(Baseline, 6 months and 1 year.)
- Change from baseline in the degree of cognitive impairment (in substudies B and C)(Baseline, 6 months and 1 year.)
- Changes in pulsatility index in middle cerebral artery (MCA) (in substudy C)(Baseline, 6 months and 1 year.)