Healthy VolunteersNCT07733362
Assessment of the Immunomodulatory Potential of Spirulina Blue Protein Capsule on Immunomodulation in Healthy Volunteers
A study testing Spirulina capsules in people with Healthy Volunteers and Immune System, run by University of Phayao at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Immune System
- What is being tested?
- Spirulina capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- 15 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rattapoom Prommana, PhD contact
Thailand1 site, 1 recruiting
- Recruiting
School of Medical Sciences, University of Phayao
Phayao, Changwat Phayao, 56000
Chutamas Thepmalee, PhD, +66 81 042 9243, th.chutamas@gmail.com
Rattapoom Prommana, PhD, rattapoom.ph@up.ac.th
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunomodulatory Potential and Safety of Spirulina Blue Protein Capsules in Healthy Volunteers
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.
Read the 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.
- Conditions
- Healthy Volunteers, Immune System
- Being tested
- Spirulina capsules
- Keywords
- Immunomodulation, Spirulina Blue Protein, Healthy Volunteers, Immune Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina capsulesDietary supplement
Spirulina Blue Protein Capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive matching placebo capsules orally once daily for 12 weeks. Receives: Dietary Supplement: Spirulina capsules |
| Spirulina Blue Protein 200 mg/day | Experimental | Participants will receive Spirulina Blue Protein capsules at a dose of 200 mg/day orally once daily for 12 weeks. Receives: Dietary Supplement: Spirulina capsules |
| Spirulina Blue Protein 1000 mg/day | Experimental | Participants will receive Spirulina Blue Protein capsules at a dose of 1,000 mg/day orally once daily for 12 weeks. Receives: Dietary Supplement: Spirulina capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Phayao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chutamas Thepmalee, University of Phayao
- Investigators
- Chutamas Thepmalee, PhD, Principal investigator, School of Medical Sciences, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733362
- Sponsor's protocol ID
- HREC-UP-2026-001
- Other IDs
- UP401/2569, TCTR20260719002
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunomodulatory Potential and Safety of Spirulina Blue Protein Capsules in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07733362
- Acronym / sponsor ID
- HREC-UP-2026-001
- Conditions
- Healthy Volunteers, Immune System
- Keywords
- Immunomodulation, Spirulina Blue Protein, Healthy Volunteers, Immune Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of PhayaoUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Spirulina capsulesParticipants will receive matching placebo capsules orally once daily for 12 weeks. |
| Spirulina Blue Protein 200 mg/day | Experimental | Dietary Supplement: Spirulina capsulesParticipants will receive Spirulina Blue Protein capsules at a dose of 200 mg/day orally once daily for 12 weeks. |
| Spirulina Blue Protein 1000 mg/day | Experimental | Dietary Supplement: Spirulina capsulesParticipants will receive Spirulina Blue Protein capsules at a dose of 1,000 mg/day orally once daily for 12 weeks. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina capsulesSpirulina Blue Protein Capsule | Dietary supplement | Placebo, Spirulina Blue Protein 1000 mg/day, Spirulina Blue Protein 200 mg/day |
Primary outcome
Change in Peripheral Blood Immune Cell Subsets
Time frame: 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.
1 secondary outcome
Change in Serum Cytokine Concentrations
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rattapoom Prommana, PhD contact
Chutamas Thepmalee, PhD principal investigator
School of Medical Sciences, University of Phayao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina capsules in people with Healthy Volunteers and Immune System, run by University of Phayao at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chutamas Thepmalee, PhD (+66 81 042 9243, th.chutamas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peripheral Blood Immune Cell Subsets (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.