Effects of Immulina on Immune Measures

NCT ID: NCT04071730

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-03-11

Brief Summary

This small, randomized, double blind, placebo controlled pilot study is aimed at determining the effects of oral Immulina dietary supplementation on specific immune biomarkers in the blood.

Detailed Description

This small, randomized, double blind, placebo controlled pilot study is aimed at determining the effects of four weeks of daily Immulina dietary supplementation (800 mg/day) versus four weeks of daily placebo on natural killer (NK) cell numbers and/or natural killer (NK) cell activity in human peripheral blood mononuclear cells collected from human research participants who meet the trial's inclusion/exclusion criteria.

Conditions

Effects of Immulina on Natural Killer Cells

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Immulina Dietary Supplementation

Immulina Dietary Supplementation - 200 mg capsules; 800 mg/day; 2 (200 mg) capsules given by mouth in the morning and 2 (200 mg) capsules given by mouth in the evening for 4 weeks duration

Group Type: EXPERIMENTAL

Immulina Dietary Supplementation

Intervention Type: DIETARY_SUPPLEMENT

Immulina Dietary Supplementation 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 - inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 4 weeks duration

Group Type: PLACEBO_COMPARATOR

Immulina Dietary Supplementation

Intervention Type: DIETARY_SUPPLEMENT

Immulina Dietary Supplementation 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

Immulina Dietary Supplementation

Immulina Dietary Supplementation 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: DIETARY_SUPPLEMENT

Other Intervention Names

Immulina; Spirulina

Eligibility Criteria

Inclusion Criteria

• Normal, generally healthy adults between ages 18-64 and who may or may not have a controlled disease(s). Examples of controlled diseases are controlled Type-2 diabetes mellitus, controlled hypertension, controlled allergic rhinitis, etc.

Exclusion Criteria

• Individuals with specific disease entities, which, in the opinion of the Principal Investigator, 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-Barre syndrome, psoriasis, Grave's disease, Hashimoto's thyroiditis, myasthenia gravis or vasculitis.
• Individuals who are unwilling to refrain for the duration of the trial from taking the specific dietary supplements and fermented food products including probiotic, microalgae or beta glucan containing dietary supplements, fermented food products (such as yogurt, bean curd, etc.).
• Pregnant females (because baseline immune responses, are altered by pregnancy)
• Individuals unable to speak, understand and read English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gailen D. Marshall Jr., MD PhD

The R. Faser Triplett, Sr., MD Chair of Allergy and Immunology, Professor of Medicine, Pediatrics, Pathology and Population Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gailen D Marshall, Jr., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

2019-0183

Identifier Type: -

Identifier Source: org_study_id