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

NCT07733362 | Recruiting

• 3 other identifiers: HREC-UP-2026-001UP401/2569TCTR20260719002
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Immune System

Keywords

Immunomodulation; Spirulina Blue Protein; Healthy Volunteers; Immune Function

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Change in Serum Cytokine Concentrations

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo capsules orally once daily for 12 weeks.

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.

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.

Dietary Supplement: Spirulina capsules

Interventions

Spirulina capsules DIETARY_SUPPLEMENT

Spirulina Blue Protein Capsule

Placebo; Spirulina Blue Protein 1000 mg/day; Spirulina Blue Protein 200 mg/day

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Phayao: lead

Study Sites (1)

School of Medical Sciences, University of Phayao

Phayao, Changwat Phayao, 56000, Thailand

RECRUITING

Study Officials

• Chutamas Thepmalee, PhD

  School of Medical Sciences, University of Phayao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chutamas Thepmalee, PhD

CONTACT

+66 81 042 9243; th.chutamas@gmail.com

Rattapoom Prommana, PhD

CONTACT

th.chutamas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, School of Medical Sciences

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)