Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome

Ki vehet részt

• ≥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

Ki nem vehet részt

• 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)
• 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)