ClinicalTrials.gg
Not yet recruitingNCT07559110SALICOLUpdated Apr 30, 2026

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)

An interventional study of Halophyte plant extracts in Dyslipidemia, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Not yet recruiting at 1 site in Spain. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Dyslipidemia

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Keywords

  • food supplement
  • polyphenol
  • Dyslipidaemia
03

In context

Dyslipidemias

1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.

This study's planned enrollment of 250 is above the median of 100 across 986 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Treatment

    Food supplement to be taken once a day.

    Dietary Supplement: Halophyte plant extracts

  • No intervention
    Clinical practice

    Without intervention

Interventions

  • Dietary supplementHalophyte plant extracts

    Dietary supplement based on halophyte plant extracts (experimental) plus regular medical treatment. Dosage: once daily. Duration of study: 3 months.

06

What researchers measure

Primary outcomes

  1. Total cholesterol (g/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  2. Low Density Lipoprotein cholesterol (mg/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  3. Oxidation of Low Density Lipoprotein cholesterol (mg/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  4. High-Density Lipoprotein cholesterol (mg/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  5. Triglycerides (mg/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  6. Remnant cholesterol (mg/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  7. Apolipoprotein B (mg/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  8. Lipoprotein (a) (mg/dL)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Sodium (mEq/L)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  2. Potassium (mEq/L)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  3. Homocysteine (µmol/L)

    Measurement of changes in blood tests in patients taking the dietary supplement compared to patients following standard clinical practice.

    Time frame: Baseline and 3 months

  4. Count of returned treatment capsules.

    Confirm adequate adherence to dietary supplementation.

    Time frame: 3 months

  5. Severity of the adverse event

    \- 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.

    Time frame: 3 months

  6. Blood pressure (mmHg)

    Time frame: Baseline and 3 months.

  7. Assessment of change in Systematic Coronary Risk Estimation (SCORE) over time

    \<1 low-risk; \>=1 to \<5 moderat- risk; \>=5 to \<10 high-risk; \>=10 very-high-risk

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — 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).

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for May 2026, 0 months later.

Of 194 non-industry interventional studies with no phase under Dyslipidemias, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 42. This study's planned 0 months is below that.

Counting every sponsor, half of 205 studies reached it within 16 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2026
First posted
Apr 30, 2026
StartEst.
May 2026
Primary completionEst.
May 2026
CompletionEst.
May 2027
Last update
Apr 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07559110
Collaborators
Joan Montaner Villalonga
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
May 2026 (estimated)
Primary completion
May 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Apr 30, 2026

Study contacts

University Hospital Virgen Macarena
Contact
neurovascular.macarena@gmail.com
+34608114878
Soledad Pérez Sánchez
principal investigator · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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