Assessment of the Immunomodulatory Potential of Spirulina Blue Protein Capsule on Immunomodulation in Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260719002

Enrollment

Registered

2026-07-19

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune function Healthy adults Spirulina Arthrospira platensis Dietary Supplements Immune System Immunity Cytokines Natural Products Safety T Lymphocytes Natural Killer Cells Immunomodulation

Interventions

Participants will receive placebo capsules orally once daily for 12 weeks. The placebo capsules will have a similar appearance to the Spirulina blue protein capsules but will contain no active Spiruli

Placebo Comparator Other,Active Comparator Dietary Supplement,Active Comparator Dietary Supplement

Placebo,Spirulina blue protein 200 mg per day,Spirulina blue protein 1000 mg per day

Eligibility

Sex/Gender

All

Age

25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged 25-60 years, 2. Healthy individuals with a BMI between 18.5 and 24.9 kg/m2., 3. Participants who voluntarily agree to participate in the study by providing written informed consent., 4. Participants who are willing and able to comply with all study procedures.

Exclusion criteria

Exclusion criteria: 1. Participants with underlying diseases affecting immune or metabolic functions, including cardiovascular disease, diabetes, liver disease, kidney disease, immune disorders, or chronic inflammatory diseases., 2. Participants with abnormal laboratory results outside the reference range, including complete blood count, liver function tests, or renal function tests., 3. Participants using medications or dietary supplements that may affect study outcomes., 4. Participants with a history of allergy to Spirulina algae, Spirulina-containing products, or any components of the study capsules are excluded. 5. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Immune cell population Baseline and week 12 Percentage of CD4 T cells CD8 T cells and natural killer cells measured by flow cytometry,Cytokine profile Baseline and week 12 Serum cytokine levels including IL2, IL6, IFN gamma and TNF alpha measured by immunoassay	—

Secondary

Measure	Time frame
Safety laboratory parameters Baseline and week 12 Assessment of complete blood count renal function including serum creatinine and blood urea nitrogen BUN and liver function including AST and ALT levels	—

Countries

Thailand

Contacts

Public ContactChutamas Thepmalee

University of Phayao

th.chutamas@gmail.com0810429243

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026