Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

NCT05447078 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 2020-00201U19AT010838-01
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Immulina TM; Natural Killer Cells (NK); Botanical Dietary Supplement; Influenza; Dietary Supplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Natural Killer (NK) cell count

  20 weeks

• Cytotoxic T lymphocyte (CTL) number

  20 weeks

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

  20 weeks

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

  20 weeks

• Influenza A IgG antibody, U/mL

  20 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Immulina TM 200 mg/day

EXPERIMENTAL

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 400 mg/day

EXPERIMENTAL

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 800 mg/day

EXPERIMENTAL

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

Interventions

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.

Also known as: Spirulina

Immulina TM 200 mg/day; Immulina TM 400 mg/day; Immulina TM 800 mg/day

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Gailen D Marshall Jr., MD, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 7, 2022
• Study Start: July 1, 2022
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: July 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)