Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| People Science, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Study Product 50mg Dose | Experimental | 50mg of Study Product |
|
| Group 2: Study Product 200mg Dose | Experimental | 200mg of Study Product |
|
| Group 3: Matching Placebo | Placebo Comparator | Participants will receive Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Defense Protein 50mg Dose | Dietary Supplement | IDP dose of 50mg |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
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
C. Immunosuppressive Therapy:
Participants on:
Other Concomitant Conditions and Therapies:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noah Craft, M.D., Ph.D | Contact | 213-328-0919 | noah@peoplescience.health | |
| Azure Grant | Contact | azure@peoplescience.health |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People Science, Inc. | Recruiting | Los Angeles | California | 90045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007290 | Inosine Diphosphate |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IDP 200mg Dose |
| Dietary Supplement |
IDP dose of 200mg |
|
| Matching Placebo | Dietary Supplement | Matching Placebo |
|
| 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 |
| 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 |
| 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 |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D010850 | Picornaviridae Infections |
| D008171 | Lung Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |