Immune Defense Protein's effect on cold and flu symptoms in older adults

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of IDP® Supplement on Respiratory Immune Health Outcomes During Cold and Flu Season in Older Individuals

This project will test whether the IDP® supplement shortens and eases cold and flu symptoms in people aged 60 and older.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Quantec Ltd (industry)
• Drugs / interventions: infliximab, adalimumab, tofacitinib, chemotherapy, radiation, prednisone
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT07431840 on ClinicalTrials.gov

What this trial studies

This is a consumer-driven, decentralized observational study that follows adults 60 and older who have chosen to try the IDP® supplement. Participants report symptoms, medication use, quality of life, and tolerability using surveys in the Chloe smartphone app while product is shipped to their home. The study compares self-reported duration and severity of upper respiratory symptoms across product groups (two IDP doses and a matching placebo) and tracks rescue medication use and daily activities. All data are collected remotely through participant-reported outcome measures completed at home.

Who should consider this trial

Good fit: Adults aged 60 or older in the United States who commonly experience upper respiratory symptoms, can read English, use a smartphone, and are willing to try the IDP supplement and report symptoms via the Chloe app.

Not a fit: People who are immunocompromised or receiving chemotherapy/immunosuppressive therapy, those unable to use a smartphone or receive shipments in the U.S., or those under 60 are unlikely to benefit from or be eligible for this participant-driven program.

Why it matters

Potential benefit: If successful, this could help older adults recover faster and have milder cold and flu symptoms, improving daily functioning and reducing the need for rescue medicines.

How similar studies have performed: Prior trials of over-the-counter immune supplements have produced mixed results, and there is limited published clinical evidence specifically for the IDP formulation in older adults.

Eligibility criteria

Inclusion Criteria:

1. Age 60 years and older
2. Individuals who experience upper respiratory symptoms (e.g. coughing, sneezing, congestion) at least 2-3 times during the cold/flu season.
3. Able to read and understand English.
4. Able to read, understand, and provide informed consent.
5. Able to use a personal smartphone device and download Chloe by People Science.
6. Able to receive shipment of the product at an address within the United States.

Exclusion Criteria:

Any potential participants who:

1. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
2. Already in an immunocompromised state, including:

   A. Infectious Causes
   * HIV/AIDS
   * Chronic hepatitis B or C (advanced stages)
   * Tuberculosis (especially disseminated or extrapulmonary TB) B. Cancer-Related
   * Leukemia (e.g., AML, ALL, CLL)
   * Lymphoma (e.g., Hodgkin's and Non-Hodgkin's)
   * Multiple Myeloma
   * Any metastatic cancer receiving chemotherapy

   C. Immunosuppressive Therapy:

   Participants on:
   * Corticosteroids (e.g., ≥20 mg/day of prednisone for ≥2 weeks)
   * Biologics (e.g., TNF inhibitors like infliximab, adalimumab)
   * Calcineurin inhibitors (e.g., tacrolimus, cyclosporine)
   * mTOR inhibitors (e.g., sirolimus)
   * JAK inhibitors (e.g., tofacitinib)
   * Chemotherapy or radiation therapy
   * Anti-rejection meds post-organ transplant D. Transplant Patients
   * Solid organ transplant (kidney, liver, heart, lung)
   * Hematopoietic stem cell transplant (HSCT) E. Autoimmune or Inflammatory Diseases (especially when treated with immunosuppressants)
   * Rheumatoid Arthritis
   * Systemic Lupus Erythematosus (SLE)
   * Psoriasis or Psoriatic Arthritis
   * Inflammatory Bowel Disease (Crohn's disease, Ulcerative colitis)
   * Multiple Sclerosis (especially on disease-modifying therapies)
3. Other Concomitant Conditions and Therapies:

   1. Any investigational therapies or treatments within 30 days prior to enrollment.
   2. Known diagnosis of Asthma and/or COPD
   3. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
   4. Any underlying medical conditions or comorbidities that may confound the evaluation of the study outcomes
   5. Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes
4. Use of cannabis-containing products daily
5. Use of nicotine-containing products daily
6. Known hypersensitivity or previous allergic reaction to milk products, Sorbitol and/or tabletting aids.
7. Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.

Where this trial is running

Los Angeles, California

• People Science, Inc. — Los Angeles, California, United States (RECRUITING)

Study contacts

• Study coordinator: Noah Craft, M.D., Ph.D

Conditions: Upper Respiratory Disease, Influenza, Viral Upper Respiratory Infection, Cold, Flu, URI, Lungs, Upper Respiratory Tract