Assessment of the Immunomodulatory Potential of Spirulina Blue Protein Capsule on Immunomodulation in Healthy Volunteers | NCT07733362

NCT07733362

Overview

NCT ID: NCT07733362
Lead Sponsor: University of PhayaoOTHER
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunomodulatory Potential and Safety of Spirulina Blue Protein Capsules in Healthy Volunteers
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

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Central Contacts: Chutamas Thepmalee, PhDContact
th.chutamas@gmail.com+66 81 042 9243

Participant Group/Arms

PlaceboPlacebo Comparator

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

Dietary Supplement: Spirulina capsules

Spirulina Blue Protein 200 mg/dayExperimental

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/dayExperimental

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