Effects of Food Intake on Biomarker Activity in Normal Humans Taking Immulina

NCT07893314 | Not Yet Recruiting Phase 2

• 1 other identifier: NIH R33 Project
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The need for a generally available product that can safely and effectively increase antiviral resilience in susceptible populations became highly relevant during the recent COVID pandemic. The value continues with the endemic influenza season, which is now joined by COVID and, in susceptible adults, respiratory syncytial virus. The investigators recently completed a NIH-funded U19 project examining the immune potentiating effects of Immulina supplementation on biomarkers associated with antiviral resilience. Results showed robust NK responses in a substantial minority of participants. Further work has shown that the active compounds in Immulina (Braun-type lipoproteins) may be susceptible to degradation under GI conditions that are typically found during digestion after a meal (such as locally elevated intestinal pancreatic lipase and surfactant levels in the post meal state). In the investigators initial study, no instruction was given about when to take the investigational product in relationship to a meal or any restrictions on fat content indicating a possible spectrum of intestinal chemical conditions that could have affected the bioactivity of Immulina in different members of the study cohort. Because of the heterogeneous immune biomarker response in the investigators U19 study cohort, the investigators propose to explore the role of food presence when ingesting the supplement and its possible impact on the immunostimulatory properties of Immulina. The investigators will address this question by seeking to characterize and optimize the oral delivery of Immulina through evaluating product quality, bio accessibility, and stability under simulated GI conditions relevant to fasting and fed states. This will be accomplished through botanical authentication, bioassay-based standardization, and dissolution performance of the clinical encapsulated product to ensure consistency with previously characterized material. Additionally, investigators will perform in vitro studies to identify dietary conditions most likely to preserve Immulina activity. Further, an additional pharmacodynamic study will be performed with various Immulina doses over four weeks in individuals who will fast for 2 hours or have just completed a meal after taking daily dose of Immulina to compare the effects of fed vs 2 hr. fasting after ingesting Immulina on biomarkers of antiviral resilience. Finally, investigators will examine the effects of a 4-week pretreatment with Immulina vs. placebo on vaccine-specific antibody titers after routine influenza immunization by comparing vaccine-specific antibody titers immediately prior and 4 weeks after immunization. These studies will allow optimal design of future clinical trial protocols to assess impact of daily Immulina on antiviral resilience in susceptible populations with or without known immune compromise due to concomitant disease (e.g. cancer, transplant, etc.) or age (e.g., immune senescence).

Conditions

Viral Diseases

Keywords

Immulina; Resilience; Immune; NK

Outcome Measures

Primary Outcomes (1)

• Changes in NK cell activity after ingesting Immulina for 4 Weeks

  NK cell activity in peripheral quantified by percent NK cytotoxicity measured via the Cayman Chemical 7-AAD/CFSE Cell-Mediated Cytotoxicity Assay at baseline, 2 and 4 weeks after ingesting daily IP

  baseline, 2, 4 weeks after starting IP

Study Arms (6)

Immulina 400mg, fasting

EXPERIMENTAL

daily ingestion for 4 weeks of Immulina 400mg with subsequent fast for 2 hrs before eating breakfast

Dietary Supplement: Immulina

Immulina 800mg fasting

EXPERIMENTAL

daily ingestion for 4 weeks of Immulina 800mg with subsequent fast for 2 hrs before eating breakfast

Dietary Supplement: Immulina

Immulina Placebo, fasting

PLACEBO COMPARATOR

daily ingestion for 4 weeks of placebo with subsequent fast for 2 hrs before eating breakfast

Other: Placebo

Immulina 400mg Fed

EXPERIMENTAL

daily ingestion for 4 weeks of Immulina 400mg taken with breakfast

Dietary Supplement: Immulina

Immulina 800mg Fed

EXPERIMENTAL

daily ingestion for 4 weeks of Immulina 800mg taken with breakfast

Dietary Supplement: Immulina

Immulina Placebo Fed

PLACEBO COMPARATOR

daily ingestion for 4 weeks of placebo taken with breakfast

Other: Placebo

Interventions

Immulina DIETARY_SUPPLEMENT

commercially available GWAS extract from Spirulina cyanobacteria

Immulina 400mg Fed; Immulina 400mg, fasting; Immulina 800mg Fed; Immulina 800mg fasting

Placebo OTHER

capsule matched biologically inactive vehicle

Immulina Placebo Fed; Immulina Placebo, fasting

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18-99
• 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. This can be expected to include patients with stable chronic diseases such as cardiovascular, malignant, diabetes mellitus and HIV
• 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, surgery or significant injury within 30 days of enrollment
• 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 to each participant
• treatment with any agents that have demonstrated immunosuppressive properties.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

MeSH Terms

Conditions

Virus Diseases

Interventions

Immulina

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Gailen D Marshall, MD PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gailen D Marshall, MD PhD

CONTACT

6018151078; gmarshall@umc.edu

Katrina Mcdowell

CONTACT

601-815-1078; kmcdowell1@umc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after study completion when data are analyzed and reported back to NIH and published, all data will be made publicly available. Estimated by Jan 1, 2031
• Access Criteria: after study completion when data are analyzed and reported back to NIH and published, all data will be made publicly available