What is this study investigating about cardiovascular risk and the gut microbiome?

This study is evaluating how supplements of Spirulina Arthrospira platensis and Gelidium corneum may affect markers related to heart health and gut bacteria. Researchers want to understand if these algae supplements can influence factors like blood lipids, blood pressure, and microbiome composition. The study is led by Universidade do Porto and aims to provide quality evidence on these effects.

Who may be eligible for this cardiovascular health clinical trial?

Adults aged 50 years or older with a history of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease, albuminuria, or diabetes may be eligible. Both men and women can participate, but women must meet certain reproductive criteria. Participants must not have taken antibiotics in the last 30 days. Please review eligibility criteria for more details.

Is there any cost to participate in this cardiovascular health clinical trial?

Study-related care, including the study supplements and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to attend scheduled visits for assessments and sample collections without paying for the study treatments.

Actively Recruiting

Phase Not Applicable

Age: 50Years +

All Genders

ID07173062

Study on the Effects of Spirulina and Gelidium Algae Supplements on Heart Health and Gut Microbiome in Adults Over 50

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

150

Participants Needed

Research Sites

N/A

Total Duration

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

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

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

Research Team

Francisca Saraiva, PhD

Janete Santos, PhD

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