Actively Recruiting
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
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 (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
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
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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