Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447078
• Other study ID #: 2020-0020
• Secondary ID: 1U19AT010838-01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: University of Mississippi Medical Center
• Contact: Donielle Drakes, MBA
• Phone: 6014967821
• Email: ddrakes[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 472
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• 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.
• Placebo
Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Natural Killer (NK) cell count	Differences in NK cell counts from baseline to 20 weeks	20 weeks
Secondary	Cytotoxic T lymphocyte (CTL) number	Differences in CTL counts from baseline to 20 weeks	20 weeks
Secondary	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
Secondary	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
Secondary	Influenza A IgG antibody, U/mL	Differences in Influenza A IgG antibody U/mL from baseline to 20 weeks	20 weeks
Secondary	Influenza B IgG antibody, U/mL	Differences in Influenza B IgG antibody U/mL from baseline to 20 weeks	20 weeks
Secondary	serum Interferon gamma, pg/mL	Differences in Interferon gamma levels from baseline to 20 weeks	20 weeks
Secondary	serum Interferon alpha, pg/mL	Differences in Interferon alpha levels from baseline to 20 weeks	20 weeks