RecruitingNot ApplicableNCT07173062

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


Sponsor

Universidade do Porto

Enrollment

150 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether eating algae (seaweed-based supplements) can improve cardiovascular risk markers and gut bacteria in older adults who already have heart disease, diabetes, or kidney disease. **You may be eligible if...** - You are 50 or older with a BMI of 20 or above - You have a history of stroke, heart disease, peripheral artery disease, chronic kidney disease, significant protein in your urine, or diabetes - You have not taken antibiotics in the past 30 days - If you are a woman, you must be post-menopausal, surgically sterile, or using reliable contraception **You may NOT be eligible if...** - You have taken antibiotics recently (within 30 days) - You are pregnant or of childbearing potential without using contraception - You are unable to attend study visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSpirulina Arthrospira platensis (microalgae)

Spirulina Arthrospira platensis (4 x \~500mg), taken twice daily as 2 capsules in the morning + 2 capsules in the evening

DIETARY_SUPPLEMENTGelidium corneum

Gelidium corneum (4 x \~500mg), taken twice daily as 2 capsules in the morning + 2 capsules in the evening

OTHERPlacebo

Microcrystalline cellulose, silicon dioxide and dicalcium phosphate (4 x \~500mg), taken twice daily as 2 capsules in the morning + 2 capsules in the evening


Locations(1)

Unidade Local de Saúde de São João

Porto, Portugal

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NCT07173062


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