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

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza; Upper Respiratory Disease; Viral Upper Respiratory Infection
• Intervention / Treatment: Dietary supplement: Immune Defense Protein 50mg Dose; Dietary supplement: IDP 200mg Dose; Dietary supplement: Matching Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noah Craft, M.D., Ph.D; Phone Number: 213-328-0919; Email: noah@peoplescience.health
• Study Contact Backup: Name: Azure Grant; Email: azure@peoplescience.health

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Recruiting
      • People Science, Inc.
      • Contact: Noah Craft, M.D., Ph.D; Phone Number: 213-328-0919; Email: noah@peoplescience.health
      • Contact: Azure Grant; Email: azure@peoplescience.health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Study Product 50mg Dose; 50mg of Study Product	Dietary supplement: Immune Defense Protein 50mg Dose; IDP dose of 50mg
Experimental: Group 2: Study Product 200mg Dose; 200mg of Study Product	Dietary supplement: IDP 200mg Dose; IDP dose of 200mg
Placebo Comparator: Group 3: Matching Placebo; Participants will receive Matching Placebo	Dietary supplement: Matching Placebo; Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on Upper Respiratory Symptom Incidence, Duration and Severity	To evaluate the impact of IDP® Preventative Supplementation on incidence of upper respiratory symptoms, and the duration and severity of any symptoms that occur by measuring the change in incidence of upper respiratory symptoms (frequency, type, duration and severity) between study product and placebo groups. Baseline will be compared as well.	17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on Rescue Medications	To evaluate the impact of IDP® Supplement on the frequency of use and type of rescue medications by measuring the change in the daily use and type of rescue medications used for Upper Respiratory symptoms between product and placebo groups. Baseline will be compared as well.	17 weeks
Safety and Tolerability Assessment	To evaluate the tolerability of IDP® Supplement by assessing the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product and placebo use period.	16 weeks
Impact of IDP on Upper Respiratory Symptoms	To evaluate the impact of IDP® Supplement on Upper Respiratory symptoms by evaluating the change in Wisconsin Upper Respiratory Symptom Survey score ranging from a minimum of 0 (no symptoms) to a maximum of 140 (maximum severity), between product and placebo groups. Baseline will be compared as well.	17 weeks
Impact on Quality of Life	To evaluate the impact of IDP® on quality of life by measuring the change in the 36-Item Short Form Health Survey (SF-36) between product and placebo groups. The raw scores are transformed into a 0-100 scale, where 0 represents the lowest/worst health state and 100 the highest/best health state. Baseline will be compared as well.	17 weeks

Collaborators and Investigators

• Sponsor: Quantec Ltd
• Collaborators: People Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pneumonia; Influenza; Flu; Lungs; Cold; URI; Upper Respiratory Tract; Viral Upper Respiratory Infection; Upper Respiratory
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Picornaviridae Infections; Influenza, Human; Pneumonia; Respiration Disorders; Common Cold; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Ribonucleotides; Nucleotides; Purine Nucleotides; Inosine Nucleotides; Inosine Diphosphate
• Other Study ID Numbers: PS23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No