Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID07173062

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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