RecruitingNot ApplicableNCT07733362

Assessment of the Immunomodulatory Potential of Spirulina Blue Protein Capsule on Immunomodulation in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunomodulatory Potential and Safety of Spirulina Blue Protein Capsules in Healthy Volunteers


Sponsor

University of Phayao

Enrollment

54 participants

Start Date

Aug 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and immunomodulatory effects of Spirulina Blue Protein capsules in healthy adults. Participants will be randomly assigned to receive placebo, 200 mg/day, or 1,000 mg/day of Spirulina Blue Protein capsules for 12 weeks. The study will assess changes in immune cell populations (CD4+, CD8+, and natural killer cells), circulating cytokine levels, hematological and biochemical parameters, and the occurrence of adverse events. The findings will provide evidence regarding the safety and potential immunomodulatory benefits of Spirulina Blue Protein supplementation in healthy individuals and support the development of evidence-based functional food and nutraceutical products.


Eligibility

Min Age: 25 YearsMax Age: 60 Years

Inclusion Criteria4

  • Healthy male or female adults aged 25-60 years.
  • Body mass index (BMI) between 18.5 and 24.9 kg/m².
  • Able and willing to provide written informed consent.
  • Willing and able to comply with all study procedures and scheduled visits

Exclusion Criteria5

  • History of diseases affecting the immune system or metabolism, including cardiovascular disease, diabetes mellitus, liver disease, kidney disease, autoimmune disorders, or chronic inflammatory diseases.
  • Abnormal laboratory findings outside the reference range, including complete blood count, liver function tests, or renal function tests.
  • Current use of medications or dietary supplements that may affect the study outcomes.
  • Known allergy to Spirulina, algae-containing dietary supplements, or any component of the study capsules.
  • Pregnant or breastfeeding women.

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Interventions

DIETARY_SUPPLEMENTSpirulina capsules

Spirulina Blue Protein Capsule


Locations(1)

School of Medical Sciences, University of Phayao

Phayao, Changwat Phayao, Thailand

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NCT07733362


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