NCT06076122

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

October 10, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

September 4, 2023

Last Update Submit

October 3, 2023

Conditions

StrokeIschemic StrokeNeurovascular InjuryBrain Ischemia

Keywords

PolyphenolSalicorniaBrain ischemiaNeuroprotectionHalophytes

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    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.

    Through study completion, up to 1 year.

Secondary Outcomes (12)

  • Participants with change from baseline in blood cholesterol

    Baseline and up to 1 year.

  • Participants with change from baseline in blood homocysteine

    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 Fatty acid-binding protein 2 (FABP2)

    Baseline and up to 1 year.

  • Change from baseline in the degree of cognitive impairment (in substudies B and C)

    Baseline, 6 months and 1 year.

  • +7 more secondary outcomes

Study Arms (2)

Food supplement based on Salicornia extracts

EXPERIMENTAL

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).

Dietary Supplement: Food supplement based on Salicornia extracts

Placebo

PLACEBO COMPARATOR

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).

Dietary Supplement: Placebo

Interventions

Food supplement based on Salicornia extractsDIETARY_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.

Also known as: Salicornia extracts
Food supplement based on Salicornia extracts
PlaceboDIETARY_SUPPLEMENT

Placebo capsules physically equal to the Salicornia extracts capsules

Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years old
  • Possibility of analytical controls at the beginning/end of the study.
  • Willingness and ability to give informed consent.

You may not qualify if:

  • 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:
  • 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.
  • +48 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

StrokeIschemic StrokeBrain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joan Montaner Villalonga

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Multicentre, randomised, triple-blind, parallel-group, placebo-controlled pilot trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

October 10, 2023

Study Start

September 15, 2022

Primary Completion

February 9, 2023

Study Completion

October 31, 2023

Last Updated

October 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Analyzed data will be published as a whole

Locations

ES(1)