Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

University of Mississippi

Status and phase: Completed; Phase 3

Conditions: Healthy Volunteers

Treatments: Drug: Immulina TM; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05447078

2020-0020

1U19AT010838-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 492 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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492 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 16 weeks duration.

Treatment:

Dietary Supplement: Placebo

Immulina TM 200 mg/day

Experimental group

Description:

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.

Treatment:

Drug: Immulina TM

Immulina TM 400 mg/day

Experimental group

Description:

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.

Treatment:

Drug: Immulina TM

Immulina TM 800 mg/day

Experimental group

Description:

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.

Treatment:

Drug: Immulina TM