Immune Defense Protein Impact On Respiratory Immune Outcomes

Official title

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

Overview

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.

Detailed description

The rationale for this study is to observe the impact of IDP® Supplement on upper respiratory tract symptoms, including duration and severity, in older individuals during the cold and flu season. Additionally, the study aims to observe the impact of the product on the type and frequency of use of rescue medication(s), the impact on individuals' activities and quality of life, and the overall tolerability of the study product. These endpoints will be assessed via activities and technologies that can successfully and effectively be completed in a home setting. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the impact of this product in this population.

The investigators will examine the outcomes in adults aged 60 years or older who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and questionnaires completed at-home using the Chloe App. Findings from this study will contribute knowledge toward the tolerability, formulation, and design of future studies.

Interventions

• 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

Primary outcome measures

• Impact on Upper Respiratory Symptom Incidence, Duration and Severity [Time frame: 17 weeks]

Secondary outcome measures (4)

• Impact of IDP on Upper Respiratory Symptoms [Time frame: 17 weeks]
• Impact on Rescue Medications [Time frame: 17 weeks]
• Impact on Quality of Life [Time frame: 17 weeks]
• Safety and Tolerability Assessment [Time frame: 16 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Any potential participants who:

• Do not have a personal smartphone, internet access, or unwilling to download Chloe.
• 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)
• Other Concomitant Conditions and Therapies:

• Any investigational therapies or treatments within 30 days prior to enrollment.
• Known diagnosis of Asthma and/or COPD
• Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
• Any underlying medical conditions or comorbidities that may confound the evaluation of the study outcomes
• 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
• Use of cannabis-containing products daily
• Use of nicotine-containing products daily
• Known hypersensitivity or previous allergic reaction to milk products, Sorbitol and/or tabletting aids.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• People Science, Inc. — Los Angeles

Identifiers

NCT: NCT07431840 · PS23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗