Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05447078
Other study ID # 2020-0020
Secondary ID 1U19AT010838-01
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2026

Study information

Verified date August 2023
Source University of Mississippi Medical Center
Contact Donielle Drakes, MBA
Phone 6014967821
Email ddrakes@umc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 472
Est. completion date June 30, 2026
Est. primary completion date December 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Mississippi Medical Center Jackson Mississippi

Sponsors (2)

Lead Sponsor Collaborator
University of Mississippi Medical Center National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Natural Killer (NK) cell count Differences in NK cell counts from baseline to 20 weeks 20 weeks
Secondary Cytotoxic T lymphocyte (CTL) number Differences in CTL counts from baseline to 20 weeks 20 weeks
Secondary Plasma cytokine profile; IL1b, IL6, TNF alpha, IL2, IL7, IL12, IL15 and IL18; pg/mL Differences in plasma cytokine profiles from baseline to 20 weeks 20 weeks
Secondary Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts CD3 (mature T cells), CD4(T helper/inducer cell), CD8 (T suppressor/cytotoxic cell), CD25 (IL2 suppressor), FoxP3 (T regulator cell), IL10 (T regulatory suppressor cell), Interferon gamma (T helper 1 cell), IL4 (T helper 2 cell) and TGF beta (T regulatory suppressor cell) counts in human peripheral blood mononuclear cells measured by flow cytometry.
Differences in Immunophenotyping panel biomarker counts from baseline to 20 weeks
20 weeks
Secondary Influenza A IgG antibody, U/mL Differences in Influenza A IgG antibody U/mL from baseline to 20 weeks 20 weeks
Secondary Influenza B IgG antibody, U/mL Differences in Influenza B IgG antibody U/mL from baseline to 20 weeks 20 weeks
Secondary serum Interferon gamma, pg/mL Differences in Interferon gamma levels from baseline to 20 weeks 20 weeks
Secondary serum Interferon alpha, pg/mL Differences in Interferon alpha levels from baseline to 20 weeks 20 weeks
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1