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Dietary Supplement
Immulina Supplement for Enhancing Viral Resilience in Healthy Subjects
N/A
Recruiting
Led By Gailen D Marshall, Jr., MD, PhD
Research Sponsored by University of Mississippi Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-59 (study group 1) or ages 65 and above (study group 2)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
Study Summary
This trial will test if the oral supplement Immulina can help people be more resilient to the effects of the flu virus.
Who is the study for?
This trial is for healthy adults in two age groups: 18-59 and 65 or older. Participants must have stable chronic illnesses, with no changes to their medical treatments within the last month. They should understand what's required for the study and be able to attend multiple clinic visits.Check my eligibility
What is being tested?
The trial tests Immulina TM, an oral supplement, against a placebo to see if it can boost resilience against viral influenza infection. It's a randomized, double-blind study meaning participants are randomly assigned to either the supplement or placebo group without knowing which one they receive.See study design
What are the potential side effects?
Since this trial involves healthy subjects taking an oral supplement designed to enhance immune function, side effects might include digestive discomfort or allergic reactions but specific side effects will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either between 18-59 years old or 65 years or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Natural Killer Cells
Secondary outcome measures
Cytotoxic T-Lymphocytes
Immunophenotyping panel biomarkers- CD3, CD4, CD8, CD25, FoxP3, IL10, Interferon gamma, IL4, TGF beta counts
Influenza A IgG antibody, U/mL
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Immulina TM 800 mg/dayExperimental Treatment1 Intervention
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 II: Immulina TM 400 mg/dayExperimental Treatment1 Intervention
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 III: Immulina TM 200 mg/dayExperimental Treatment1 Intervention
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 IV: PlaceboPlacebo Group1 Intervention
inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 16 weeks duration.
Find a Location
Who is running the clinical trial?
University of Mississippi Medical CenterLead Sponsor
173 Previous Clinical Trials
194,615 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,461 Total Patients Enrolled
Gailen D Marshall, Jr., MD, PhDPrincipal InvestigatorUniversity of Mississippi Medical Center
4 Previous Clinical Trials
164 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to commit to multiple clinic visits for research.My chronic illness has been stable for at least 30 days.I am either between 18-59 years old or 65 years or older.
Research Study Groups:
This trial has the following groups:- Group 1: Immulina TM 400 mg/day
- Group 2: Immulina TM 200 mg/day
- Group 3: Placebo
- Group 4: Immulina TM 800 mg/day
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being accepted for participation in this experiment?
"This medical experiment is in the process of sourcing participants, with its inception on July 1st 2022 and most recent update occurring August 23rd."
Answered by AI
How many participants are included in this research project?
"Affirmative. Per the information on clinicaltrials.gov, this investigation is actively inviting volunteers to participate in their research - with first postings occurring on July 1st 2022 and last updated August 23rd 2022 – seeking a total of 472 participants from one site."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
How old are they?
18 - 65
What site did they apply to?
University of Mississippi Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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