Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT07246850
Eligibility Criteria:
Inclusion Criteria:
* Be male or female
* Be aged 18-65
* Meet at least one of the following criteria:
Work in a hospital or other healthcare setting Work in a school
* Have a child/children under the age of 10
* Be willing to take the test or placebo product once daily and complete study questionnaires every four weeks for the 16-week study period
* Be willing to refrain from taking any over-the-counter products, herbal remedies, or supplements that target immune function during the study period and for two weeks prior.
* Be willing to maintain their current diet, sleep schedule, and activity level for the duration of the study.
* Be in good general health and not live with any uncontrolled chronic conditions.
* Reside in the United States.
Exclusion Criteria:
* Has undergone any surgeries or invasive treatments in the past six months or plans to undergo any during the study period
* Anyone with seasonal allergies
* Anyone who follows a restrictive diet (e.g., keto, vegan, raw, carnivore, etc.).
* Anyone who got a vaccination in the last 2 weeks.
* Anyone taking one or more prescription medications:
Corticosteroids: Prednisone (prednisone), Deltasone (prednisolone), Medrol (methylprednisolone), Decadron (dexamethasone), Cortef (hydrocortisone), Kenalog (triamcinolone), Flonase (fluticasone), Nasonex (mometasone) Biologics (Immunomodulating Agents): Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), Stelara (ustekinumab), Cosentyx (secukinumab), Taltz (ixekizumab), Orencia (abatacept), Simponi (golimumab), Xeljanz (tofacitinib), Rituxan (rituximab), Actemra (tocilizumab), Kineret (anakinra) DMARDs (Disease-Modifying Antirheumatic Drugs): Methotrexate (methotrexate), Plaquenil (hydroxychloroquine), Arava (leflunomide), Azulfidine (sulfasalazine), Imuran (azathioprine), CellCept (mycophenolate mofetil), Cytoxan (cyclophosphamide) JAK Inhibitors: Olumiant (baricitinib), Rinvoq (upadacitinib), Jakafi (ruxolitinib) Other Immunosuppressive Medications: Prograf (tacrolimus), Neoral, Sandimmune (cyclosporine), Rapamune (sirolimus), Zortress (everolimus)
* Has had any major illness in the past three months.
* Drinks heavily (defined as 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
* Uses illicit drugs.
* Has known allergies or hypersensitivities to any of the study product ingredients.
* Is immunocompromised due to a medical condition or due to immunosuppressive medications or treatments.
* Has any known autoimmune conditions.
* Has any chronic health conditions that could impact participation in the study, including cancer, liver, or mental health disorders.
* Has known serious allergic reactions requiring the use of an Epi-Pen.
* Is currently pregnant, trying to conceive, or breastfeeding.
* Is currently participating in another research study or plans to do so during the 16-week study period.
* Has a history of substance abuse.
* Is currently a smoker or has been a smoker in the past three months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07246850
Study Brief:
Protocol Section:
NCT07246850