Assessment of the Immunomodulatory Potential of Spirulina Blue Protein Capsule on Immunomodulation in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spirulina capsules.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers, Immune System. Basic parameters: 25 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunomodulatory Potential and Safety of Spirulina Blue Protein Capsules in Healthy Volunteers
Overview
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.
Detailed description
Spirulina Blue Protein (SBP) from Arthrospira platensis or Spirulina platensis, which is rich in the bioactive pigment-protein phycocyanin, has demonstrated antioxidant, anti-inflammatory, and immunomodulatory activities in preclinical studies. Previous in vitro investigations have shown that SBP can enhance immune cell function and modulate cytokine production; however, evidence regarding its safety and immunomodulatory effects in healthy humans remains limited. This study aims to evaluate the safety and immunomodulatory potential of SBP capsules in healthy adults under controlled clinical conditions.
This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Healthy adults aged 25-60 years will be randomly assigned three groups: placebo, SBP 200 mg/day, or SBP 1,000 mg/day. Participants will receive the assigned intervention orally for 12 weeks.
The primary objective is to evaluate the effects of SBP supplementation on immune function by assessing changes in immune cell populations and circulating cytokine levels after 12 weeks of intervention. Safety will be evaluated through the monitoring of adverse events, vital signs, complete blood count, and clinical chemistry parameters, including liver and kidney function tests. Secondary assessments include changes in hematological and biochemical parameters and tolerability of the study product.
Blood samples will be collected before and after the intervention to evaluate immune cell populations (CD4+ T cells, CD8+ T cells, and natural killer cells) and circulating cytokines, including interleukin-2 (IL-2), interleukin-6 (IL-6), interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α). Participants will also undergo routine safety assessments throughout the study.
The results of this trial will provide clinical evidence regarding the safety and immunomodulatory effects of Spirulina Blue Protein supplementation in healthy adults and will support the development of evidence-based functional foods and nutraceutical products.
Interventions
- Dietary supplement Spirulina capsules
Spirulina Blue Protein Capsule
Primary outcome measures
- Change in Peripheral Blood Immune Cell Subsets [Time frame: 12 weeks]
Secondary outcome measures (1)
- Change in Serum Cytokine Concentrations [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Thailand · 1 center
- School of Medical Sciences, University of Phayao — Phayao
Identifiers
NCT: NCT07733362 · HREC-UP-2026-001 · UP401/2569 · TCTR20260719002