Healthy Volunteers, Immune System
Conditions
Keywords
Immunomodulation, Spirulina Blue Protein, Healthy Volunteers, Immune Function
Brief 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.
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_SUPPLEMENTSpirulina capsules
Spirulina Blue Protein Capsule
Sponsors
University of Phayao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, investigators, and outcome assessors will remain blinded to treatment allocation throughout the study. Spirulina Blue Protein and placebo capsules will be identical in appearance, packaging, and labeling. Treatment allocation will be generated using a computer-generated randomization schedule and maintained until completion of data analysis or unless unblinding is required for participant safety.
Intervention model description
Participants will be randomly assigned in a parallel-group design to three study arms: placebo, Spirulina Blue Protein 200 mg/day, or Spirulina Blue Protein 1,000 mg/day. Participants and investigators will remain blinded to treatment allocation throughout the 12-week intervention. Randomization will be performed using a computer-generated randomization schedule.
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peripheral Blood Immune Cell Subsets | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Cytokine Concentrations | 12 weeks | 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. |
Countries
Thailand
Contacts
CONTACTChutamas Thepmalee, PhD
CONTACTRattapoom Prommana, PhD
PRINCIPAL_INVESTIGATORChutamas Thepmalee, PhD
School of Medical Sciences, University of Phayao
Outcome results
None listed