Evaluation of Safety and Immune Effects of Spirulina Blue Protein Capsules in Healthy Adults Aged 25 to 60

What this Trial Is About

Researchers are evaluating the safety and immune system effects of Spirulina Blue Protein capsules in healthy adults aged 25 to 60 years. This randomized, double-blind, placebo-controlled trial aims to better understand the potential immune benefits and safety of Spirulina Blue Protein, which has shown antioxidant, anti-inflammatory, and immune-modulating effects in preclinical studies but lacks sufficient human evidence. Participants will be randomly assigned to one of three groups placebo, 200 mgday Spirulina Blue Protein, or 1,000 mgday Spirulina Blue Protein capsules taken orally once daily for 12 weeks. The study will compare these groups to assess immune cell changes and cytokine levels, with interventions delivered in a parallel design over the 12-week period. During the study, participants will undergo blood sampling before and after treatment to measure immune cells like CD4, CD8, and natural killer cells, as well as cytokines such as IL-2, IL-6, IFN-, and TNF-. Safety will be monitored through vital signs, blood counts, liver and kidney tests, and tracking of any adverse events. The total participation time includes the 12-week treatment and assessments to evaluate immune function and tolerability.

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