Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection

NCT ID: NCT05447078

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-12-08

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Immulina TM 200 mg/day

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.

Group Type EXPERIMENTAL

Immulina TM

Intervention Type 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.

Immulina TM 400 mg/day

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.

Group Type EXPERIMENTAL

Immulina TM

Intervention Type 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.

Immulina TM 800 mg/day

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.

Group Type EXPERIMENTAL

Immulina TM

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Spirulina

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gailen D Marshall Jr., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2020-0020

Identifier Type: -

Identifier Source: org_study_id

1U19AT010838-01

Identifier Type: NIH

Identifier Source: secondary_id

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