Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT07173062

Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome

Led by Universidade do Porto · Updated on 2025-09-15

150

Participants Needed

1

Research Sites

72 weeks

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

The Western diet, rich in fat and sugar, contributes to cardiovascular risk and alters the body metabolism, specifically through the modulation of the microbiome. Microbiome is considered the "second genome", functioning as an endocrine-like organ. Gut microbiota-derived metabolites, namely trimethylamine- N-oxide and short-chain fatty acids have been associated with atherosclerosis, vascular and cardiac diseases. Regarding trimethylamine- N-oxide, its association with cardiovascular disease is positive and dose-dependent. In contrast, short-chain fatty acids have been positively associated with the improvement of cardiovascular health. Algae probiotics can modulate gut microbiome, stimulating the growth of commensal micro-organisms with health benefits. Previous studies suggested that Spirulina Arthrospira platensis supplementation could improve blood lipid levels and lower blood pressure, revealing anti-inflammatory and antioxidant roles. Other probiotics that could be beneficial to gut microbiota are macroalgae or seaweed. Macroalgae are a rich source of components which may prompt bacterial diversity and abundance. The present prospective, randomized, three-armed parallel trial aims to generate good-quality evidence about the potential health effects and impact of Spirulina Arthrospira platensis (microalgae) and Gelidium corneum (macroalgae) supplements in humans. These participants will undergo 3 clinical evaluations: 2 before the beginning of micro- and macro-algae supplementation and the last one after 20 weeks of supplementation. The evaluation includes a vascular, nutritional and physical activity assessment, as well as blood, urine, saliva and stool collection for quantification of plasma biomarkers, oral and gut microbiota analysis, respectively.

CONDITIONS

Official 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 (with eGFR less than 75 ml/min for at least 3 months), albuminuria over 300 mg/g, or diabetes mellitus
  • No use of antibiotics in the past 30 days
  • If female, must be of non-childbearing potential (surgically sterilized, clinically infertile, or post-menopausal with no menstruation for 12 months)
  • Female participants of childbearing potential must have a negative pregnancy test at the first visit and agree to use effective contraception consistently from 28 days before treatment until at least 7 days after last treatment
Not Eligible

You will not qualify if you...

  • Unwillingness or inability to sign informed consent (a third person may sign on patient's behalf if needed)
  • Involvement in planning or conducting this study
  • Participation in another clinical trial with investigational product within the last month
  • For participants recruited at Unidade Local de Saúde de São João: estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m2 or undergoing dialysis
  • For community recruited participants: diagnosis of end-stage renal disease or undergoing dialysis

AI-Screening

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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

CONTACT

J

Janete Santos, PhD

CONTACT

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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