Clinical trial NCT05447078: Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Healthy Volunteers
Keywords: Immulina TM
Natural Killer Cells (NK)
Botanical Dietary Supplement
Influenza
Dietary Supplementation
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-07-07
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Natural Killer cell (NK)-mediated cytotoxicity
timeFrame: 20 weeks
Secondary outcomes:
measure: Natural Killer (NK) cell count
timeFrame: 20 weeks
measure: Cytotoxic T lymphocyte (CTL) number
timeFrame: 20 weeks
measure: Plasma cytokine profile; IL1b, IL6, TNF alpha, IL2, IL7, IL12, IL15 and IL18; pg/mL
timeFrame: 20 weeks
measure: Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts
timeFrame: 20 weeks
measure: Influenza A IgG antibody, U/mL
timeFrame: 20 weeks
measure: Influenza B IgG antibody, U/mL
timeFrame: 20 weeks
measure: serum Interferon gamma, pg/mL
timeFrame: 20 weeks
measure: serum Interferon alpha, pg/mL
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: