RECRUITINGINTERVENTIONAL
Immune Defense Protein Impact On Respiratory Immune Outcomes
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
About This Trial
The primary goal of this study is to observe the impact of the IDP® Supplement on the duration and severity of upper respiratory symptoms in older individuals during the cold and flu season. Secondary aims include observing the product's effect on rescue medication use, quality of life, and overall tolerability. This is conducted as a consumer-driven, decentralized observational clinical research study in adults aged 60 or older, using self-reported measures and questionnaires completed at home via the Chloe App.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form.
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.
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DIETARY_SUPPLEMENT
Immune Defense Protein 50mg Dose
IDP dose of 50mg
DIETARY_SUPPLEMENT
IDP 200mg Dose
IDP dose of 200mg
DIETARY_SUPPLEMENT
Matching Placebo
Matching Placebo
Locations (1)
People Science, Inc.
Los Angeles, California, United States