Algae supplements for heart risk markers and gut health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with prior cardiovascular or metabolic disease will receive daily Spirulina (Arthrospira platensis), Gelidium corneum, or a placebo and will be followed to compare changes. Investigators will measure gut microbiome composition and metabolites such as trimethylamine‑N‑oxide (TMAO) and short‑chain fatty acids (SCFA), along with blood lipids and blood pressure. Participants must be 50 or older, have relevant diagnoses (stroke, CAD, MI, PAD, CKD, albuminuria, or diabetes), and have had no antibiotics in the prior 30 days. The interventions are intended to probe whether algae supplements shift microbiome‑derived metabolites toward a profile associated with lower cardiovascular risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥50 years
* BMI ≥20 kg/m2
* History of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease (eGFR \<75 ml/min at least for 3 months), albuminuria \>300 mg/g, or diabetes mellitus
* No antibiotics in the previous 30 days
* If a woman, she must be a woman of non-childbearing potential. That is, she must be:

  * Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy);
  * Clinically diagnosed infertile;
  * In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.
* A woman patient of childbearing potential must have a negative serum pregnancy test at Visit 0 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:

  * Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject);
  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
  * Intrauterine device;
  * Intrauterine hormone-releasing system;
  * Bilateral tubal occlusion;
  * Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner.

Exclusion Criteria:

* Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign/complete the informed consent form on the patient's behalf).
* Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
* Participation in another clinical study with an investigational product during the last month.
* In participants recruited at Unidade Local de Saúde de São João, the exclusion criteria applied is estimated Glomerular Filtration Rate (eGFR) \<30 ml/min/1.73m2 estimated with the CKD-EPI (2021) formula or dialysis. For participants recruited at community, this exclusion criteria is adapted for diagnosis of end-stage renal disease or dialysis (no need to quantify the eGFR).

Where it's running

• Unidade Local de Saúde de São João
  Porto, Portugal Recruiting

Study contacts

• Principal investigator: João Pedro Ferreira, MD, PhD — Universidade do Porto
• Study coordinator: Francisca Saraiva, PhD
• Email: f.saraiva@med.up.pt
• Phone: 220426820

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.