A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunomodulatory Potential and Safety of Spirulina Blue Protein Capsules in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Peripheral Blood Immune Cell Subsets
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Spirulina Blue Protein 1000 mg/day
Participants will receive Spirulina Blue Protein capsules at a dose of 1,000 mg/day orally once daily for 12 weeks.
干预措施: Spirulina capsules (Dietary Supplement)
Placebo
Participants will receive matching placebo capsules orally once daily for 12 weeks.
干预措施: Spirulina capsules (Dietary Supplement)
Spirulina Blue Protein 200 mg/day
Participants will receive Spirulina Blue Protein capsules at a dose of 200 mg/day orally once daily for 12 weeks.
干预措施: Spirulina capsules (Dietary Supplement)
结局指标
主要结局
Change in Peripheral Blood Immune Cell Subsets
时间窗: 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.
次要结局
- Change in Serum Cytokine Concentrations(12 weeks)
研究者
Chutamas Thepmalee
Associated Professor, School of Medical Sciences
University of Phayao