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Completed

NCT Number: NCT05447078

Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immulina TM

Drug

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

Placebo

Dietary Supplement

Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules.

Primary outcomes

  1. Natural Killer cell (NK)-mediated cytotoxicity

    Time frame: 20 weeks

    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.

Secondary outcomes

  1. Natural Killer (NK) cell count

    Time frame: 20 weeks

    Differences in NK cell counts from baseline to 20 weeks

  2. Cytotoxic T lymphocyte (CTL) number

    Time frame: 20 weeks

    Differences in CTL counts from baseline to 20 weeks

  3. Plasma cytokine profile; IL1b, IL6, TNF alpha, IL2, IL7, IL12, IL15 and IL18; pg/mL

    Time frame: 20 weeks

    Differences in plasma cytokine profiles from baseline to 20 weeks

  4. Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts

    Time frame: 20 weeks

    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

  5. Influenza A IgG antibody, U/mL

    Time frame: 20 weeks

    Differences in Influenza A IgG antibody U/mL from baseline to 20 weeks

  6. Influenza B IgG antibody, U/mL

    Time frame: 20 weeks

    Differences in Influenza B IgG antibody U/mL from baseline to 20 weeks

  7. serum Interferon gamma, pg/mL

    Time frame: 20 weeks

    Differences in Interferon gamma levels from baseline to 20 weeks

  8. serum Interferon alpha, pg/mL

    Time frame: 20 weeks

    Differences in Interferon alpha levels from baseline to 20 weeks

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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