NCT07431840

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Quantec Ltd · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Upper Respiratory Disease
• Influenza
• Viral Upper Respiratory Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-05
• Primary completion: 2026-05-19
• Completion: 2026-07-31
• First posted: 2026-02-25
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States