Actively Recruiting
Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome: a Placebo-controlled Randomized Double-blind Trial
Led by Universidade do Porto · Updated on 2025-09-15
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universidade do Porto
Lead Sponsor
C
Centro Hospitalar De São João, E.P.E.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how algae supplements may affect markers of cardiovascular risk and the gut microbiome in adults aged 50 and older who have certain cardiovascular or metabolic conditions. The study focuses on the impact of Spirulina Arthrospira platensis (a microalgae) and Gelidium corneum (a macroalgae) on blood lipid levels, blood pressure, inflammation, and microbiota composition. The microbiome, often called the "second genome," influences heart and vascular health through metabolites like trimethylamine-N-oxide and short-chain fatty acids. Participants will be randomly assigned to one of three groups to receive either Spirulina Arthrospira platensis, Gelidium corneum, or a placebo. Each supplement is taken as four capsules daily, split into two doses with two capsules in the morning and two in the evening, for 20 weeks. The study includes three clinical evaluations: two before starting supplementation and one after the 20-week intervention period. During the study, participants will undergo assessments of vascular health, nutrition, and physical activity, along with collections of blood, urine, saliva, and stool samples. These will be analyzed for biomarkers such as plasma trimethylamine-N-oxide and short-chain fatty acids, oral and gut microbiota, blood pressure, cholesterol levels, inflammatory markers, and kidney function. The study aims to measure changes in these factors over time to understand the potential benefits of algae supplementation on cardiovascular health.
CONDITIONS
Brief Title
Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Body mass index (BMI) of 20 kg/m2 or higher
- History of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease (eGFR less than 75 ml/min for at least 3 months), albuminuria over 300 mg/g, or diabetes mellitus
- No antibiotics use in the previous 30 days
- Women must be of non-childbearing potential (surgically sterilized, clinically infertile, or post-menopausal)
- Women of childbearing potential must have a negative pregnancy test at study start and agree to use effective contraception throughout the study
You will not qualify if you...
- Unwillingness to sign the informed consent form
- Involvement in the planning or conduct of this study
- Participation in another clinical study with an investigational product within the last month
- For certain participants, having an estimated Glomerular Filtration Rate (eGFR) less than 30 ml/min/1.73m2 or undergoing dialysis
- Diagnosis of end-stage renal disease or dialysis for community-recruited participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants take Spirulina Arthrospira platensis, Gelidium corneum, or a placebo twice daily as capsules for 20 weeks.
2 visits (Visit 1 between day 7 to day 30 and Visit 2 at 20 weeks ± 15 days from Visit 1)
Trial Site Locations
Total: 1 location
1
Unidade Local de Saúde de São João
Porto, Portugal, 4200-319
Actively Recruiting
Research Team
F
Francisca Saraiva, PhD
J
Janete Santos, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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