NCT06076122

Salicornia for Neurovascular Health Improve

Halophyte Plants as a Dietary Supplement to Improve Neurovascular Health

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	Placebo	Placebo capsules physically equal to the Salicornia extracts capsules

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-02-09
• Completion: 2023-10-31
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: Spain