NCT07173062

Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome

Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome: a Placebo-controlled Randomized Double-blind Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

• Stroke
• Coronary Arterial Disease (CAD)
• Myocardial Infarction (MI)
• Diabetes Mellitus
• Peripheral Artery Disease (PAD)
• Chronic Kidney Disease(CKD)
• Albuminuria

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Spirulina Arthrospira platensis (microalgae)	Spirulina Arthrospira platensis (4 x \~500mg), taken twice daily as 2 capsules in the morning + 2 capsules in the evening
DIETARY_SUPPLEMENT	Gelidium corneum	Gelidium corneum (4 x \~500mg), taken twice daily as 2 capsules in the morning + 2 capsules in the evening
OTHER	Placebo	Microcrystalline cellulose, silicon dioxide and dicalcium phosphate (4 x \~500mg), taken twice daily as 2 capsules in the morning + 2 capsules in the evening

Timeline

• Start date: 2025-03-11
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: Portugal