Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

Impact of Oral Immulina TM on Natural Killer Cell Activities and Other Biomarkers Associated With Increasing Host Immune Resilience to Upper Respiratory Viruses in Normal Human Volunteers

This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resilience to the effects of viral influenza infection in humans.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Drug: Immulina TM

Detailed Description

This randomized, double blind, placebo controlled study aims to establish the impact of the oral supplement, Immulina TM, on increasing host resilience against the pathogenic effects of influenza virus infection in normal and immune compromised individuals by measuring a biomarker profile designed to reflect immune components associated with antiviral natural killer cell numbers and activity, cytotoxic T cell numbers, vaccine-related flu-specific antibody responses and cytokine profiles associated with host antiviral innate and adaptive immune responses.

• Study Type: Interventional
• Enrollment (Actual): 492
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ages 18-59 (study group 1) or ages 65 and above (study group 2)
• Any chronic illness must be determined (by PI team) to be stable as evidenced by no changes in medical regimens within 30 days of enrollment.
• Ability to comprehend the specific activities required to participate in the trial for which the participant is to be enrolled.

Exclusion Criteria:

• Any acute illness or significant injury within 30 days of enrollment.
• Specific disease entities, which, in the opinion of the PI, could reasonably be assumed to have dysfunctional immune function as a component of their illness. These include HIV, AIDS, uncontrolled asthma, uncontrolled eczema, uncontrolled allergic rhinitis, uncontrolled urticaria, Rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, Type-1 diabetes mellitus, Guillain-Barr syndrome, Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis.
• Active autoimmune diseases regardless of clinical stability. A history of autoimmune disease that is not considered active (i.e. no medical therapy for at least 1 year prior to enrollment) will not be excluded.
• History of unstable chronic illness within 30 days of enrollment.
• Unable/unwilling to commit to multiple research clinic visits which will be described in detail.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 16 weeks duration.	Dietary supplement: Placebo; Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules.
Experimental: Immulina TM 200 mg/day; Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 2 placebo capsules given by mouth in the evening for 16 weeks duration.	Drug: Immulina TM; Immulina TM is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.; Other Names: Spirulina
Experimental: Immulina TM 400 mg/day; Immulina Dietary supplementation (200 mg per capsule); 1-200 mg capsule and 1 placebo capsule given by mouth in the morning and 1-200 mg capsule and 1 placebo capsule given by mouth in the evening for 16 weeks duration.	Drug: Immulina TM; Immulina TM is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.; Other Names: Spirulina
Experimental: Immulina TM 800 mg/day; Immulina Dietary supplementation (200 mg per capsule); 2-200 mg capsules given by mouth in the morning and 2-200 mg capsules given by mouth in the evening for 16 weeks duration.	Drug: Immulina TM; Immulina TM is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.; Other Names: Spirulina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural Killer cell (NK)-mediated cytotoxicity	NK cell-mediated cytotoxicity is characterized by cytolysis of a CFSE-labeled target cell (K562) by effector cells (NK cells). Labeled K562 are cultured with NK cells for a period of time, then all cells labeled with a live-dead stain, 7-AAD. The cytolytic activity is expressed as the percent dead K562. Differences in cytolytic activity (% dead K562) from baseline to 20 weeks.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural Killer (NK) cell count	Differences in NK cell counts from baseline to 20 weeks	20 weeks
Cytotoxic T lymphocyte (CTL) number	Differences in CTL counts from baseline to 20 weeks	20 weeks
Plasma cytokine profile; IL1b, IL6, TNF alpha, IL2, IL7, IL12, IL15 and IL18; pg/mL	Differences in plasma cytokine profiles from baseline to 20 weeks	20 weeks
Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts	CD3 (mature T cells), CD4(T helper/inducer cell), CD8 (T suppressor/cytotoxic cell), CD25 (IL2 suppressor), FoxP3 (T regulator cell), IL10 (T regulatory suppressor cell), Interferon gamma (T helper 1 cell), IL4 (T helper 2 cell) and TGF beta (T regulatory suppressor cell) counts in human peripheral blood mononuclear cells measured by flow cytometry. Differences in Immunophenotyping panel biomarker counts from baseline to 20 weeks	20 weeks
Influenza A IgG antibody, U/mL	Differences in Influenza A IgG antibody U/mL from baseline to 20 weeks	20 weeks
Influenza B IgG antibody, U/mL	Differences in Influenza B IgG antibody U/mL from baseline to 20 weeks	20 weeks
serum Interferon gamma, pg/mL	Differences in Interferon gamma levels from baseline to 20 weeks	20 weeks
serum Interferon alpha, pg/mL	Differences in Interferon alpha levels from baseline to 20 weeks	20 weeks

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Gailen D Marshall Jr., MD, PhD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 8, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Influenza; Dietary Supplementation; Natural Killer Cells (NK); Immulina TM; Botanical Dietary Supplement
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: 2020-0020; 1U19AT010838-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No