Assessment of the Immunomodulatory Potential of Spirulina Blue Protein Capsule on Immunomodulation in Healthy Volunteers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorUniversity of Phayao
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Spirulina capsules
Dietary supplementSpirulina Blue Protein Capsule
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Spirulina Blue Protein 200 mg/dayExperimental treatment 1 intervention
Group C: Spirulina Blue Protein 1000 mg/dayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Peripheral Blood Immune Cell Subsets
Immune cell number will be evaluated by measuring the percentages of CD4⁺ T cells, CD8⁺ T cells, and natural killer (NK) cells in peripheral blood using flow cytometry. Changes from baseline to Week 12 will be compared among the placebo, 200 mg/day Spirulina blue protein, and 1000 mg/day Spirulina blue protein groups.
Time frame
12 weeksSecondary outcomes
1
Change in Serum Cytokine Concentrations
Serum concentrations of IL-2, IL-6, IFN-γ, TNF-α, IL-1β, IL-10, and TNF-β will be measured using a multiplex immunoassay. Changes from baseline to Week 12 will be compared among the three treatment groups.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov