Salicornia for Neurovascular Health Improve

NCT ID: NCT06076122

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-10-31

Brief Summary

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.

Detailed Description

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).

Conditions

Stroke; Ischemic Stroke; Neurovascular Injury; Brain Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Food supplement based on Salicornia extracts

Participants will receive food supplement based on halophyte plant (Salicornia) extracts, 1 g (two 0.5 gram capsules) orally 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).

Group Type: EXPERIMENTAL

Food supplement based on Salicornia extracts

Intervention Type: DIETARY_SUPPLEMENT

Freshly Salicornia ramosissima plants were recollected. Its aerial part were left to dry and hydroalcoholic extracts were produced by the company Extractos Vegetales S.A. (EVESA) (Cadiz, Spain \[https://evesa.com/\]). The Salicornia extracts were encapsulated by BIO-DIS laboratories (Seville, Spain \[https://www.bio-dis.com/\]), experts in food supplements and certified for such procedures.

Placebo

Participants will receive two capsules once a day of placebo physically equal to the nutritional supplement for a treatment period of 3 months (substudy A), 11 months (substudy B), 1 year (substudy C) or 7-30 days (substudy D).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsules physically equal to the Salicornia extracts capsules

Interventions

Food supplement based on Salicornia extracts

Freshly Salicornia ramosissima plants were recollected. Its aerial part were left to dry and hydroalcoholic extracts were produced by the company Extractos Vegetales S.A. (EVESA) (Cadiz, Spain \[https://evesa.com/\]). The Salicornia extracts were encapsulated by BIO-DIS laboratories (Seville, Spain \[https://www.bio-dis.com/\]), experts in food supplements and certified for such procedures.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsules physically equal to the Salicornia extracts capsules

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Salicornia extracts

Eligibility Criteria

Inclusion Criteria

1. Patients ≥18 years old

2. Possibility of analytical controls at the beginning/end of the study.

3. Willingness and ability to give informed consent.

1. Patients ≥18 years old.

2. 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.

3. Have a neuroimaging performed at the time of the acute episode that rules out other non-vascular lesions.

4. Willingness and ability to give informed consent.

1. Patients ≥18 years of age.

2. Lacunar syndrome with acute ischaemic lesion on neuroimaging of less than 1.5 cm maximum diameter.

3. Willingness and ability to give informed consent.

1. 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:

I. Presence of silent stroke on neuroimaging.

II. Stenosis with progression (>20%).

III. Soft or ulcerated (unstable) plaque.

IV. Occlusion of contralateral internal carotid artery (ICA).

V. Impaired haemodynamic reserve.

2. Receive carotid angioplasty and stenting (CAS) of said artery within a maximum of one month after inclusion and with a minimum of one week of taking the treatment from inclusion to intervention.

3. Be able to orally take the dietary supplement/placebo from the event until just prior to the intervention.

4. Patients ≥18 years.

5. Willingness and ability to give informed consent.

Exclusion Criteria

1. Known neurovascular disease.

2. Other chronic diseases for which the subject is taking medication on a regular basis.

3. Hyperthyroidism according to the investigator's criteria.

4. Volunteers taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).

5. Severe illness with life expectancy of less than three months.

6. Known allergies or intolerance to halophyte plants.

7. Pregnant or lactating women.

8. Presence of active neoplastic disease.

9. 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.

10. Habitual consumption of halophyte plants.

11. Patients who, at the investigator's discretion, are not able to comply with the study protocol.

Substudy B:

1. Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).

2. 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.

3. Hyperthyroidism at the investigator's discretion.

4. Dysphagia that prevents the intake of the study treatment.

5. Patients dependent for basic activities of daily living (mRS >3) or with severe disease with life expectancy of less than 12 months.

6. Known allergies or intolerance to halophyte plants.

7. Habitual consumption of halophyte plants.

8. Pregnant or lactating women.

9. Presence of active neoplastic disease.

10. Patients who, at the investigator's discretion, are unable to comply with the study protocol.

Substudy C:

1. Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).

2. Hyperthyroidism at the investigator's discretion.

3. Claustrophobia or morbid obesity (IMT >40) precluding performance of MRI 3 Tesla.

4. Patients dependent for basic activities of daily living (mRS >3) or with severe disease with an expected life expectancy of less than 12 months.

5. Dysphagia that prevents the intake of the study treatment.

6. Known allergies or intolerances to halophyte plants.

7. Pregnant or breastfeeding women.

8. Presence of active neoplastic disease.

9. 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.

10. Habitual consumption of halophyte plants.

11. Patients who, at the investigator's discretion, are not able to comply with the study protocol.

Substudy D:

1. Patients taking vitamin or polyphenol-containing nutritional supplements in the 30 days prior to the screening visit (at the investigator's discretion).

2. Hyperthyroidism at the investigator's discretion.

3. Claustrophobia or morbid obesity preventing the performance of MRI 1.5 Tesla.

4. Severe disease with expected life expectancy of less than one month.

5. Dysphagia preventing the intake of the study treatment.

6. Known allergies or intolerance to halophyte plants.

7. Pregnant or lactating women.

8. Presence of active neoplastic disease.

9. 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.

10. Habitual consumption of halophyte plants.

11. Patients who, at the investigator's discretion, are not able to comply with the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Montaner Villalonga

Role: PRINCIPAL_INVESTIGATOR

Virgen Macarena (HUVM) and Virgen del Rocío University Hospitals (HUVR) and Institute of Biomedicine of Seville (iBIs)

Locations

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Ana María Najar

Role: primary

anmoyano@us.es

+34 954787742

Related Links

http://proyectosalicornia.com/

Project website

Other Identifiers

HALOPHYTES

Identifier Type: -

Identifier Source: org_study_id