Health TrialsbyHealthPanel

Immune Defense Protein Impact On Respiratory Immune Outcomes

ConditionsUpper Respiratory DiseaseInfluenzaViral Upper Respiratory Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorQuantec Ltd

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Do not have a personal smartphone, internet access, or unwilling to download Chloe.

HIV/AIDS

Chronic hepatitis B or C (advanced stages)

Tuberculosis (especially disseminated or extrapulmonary TB) B. Cancer-Related

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immune Defense Protein 50mg Dose

    Dietary supplement

    IDP dose of 50mg

  • IDP 200mg Dose

    Dietary supplement

    IDP dose of 200mg

  • Matching Placebo

    Dietary supplement

    Matching Placebo

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Group 1: Study Product 50mg DoseExperimental treatment 1 intervention
Group B: Group 2: Study Product 200mg DoseExperimental treatment 1 intervention
Group C: Group 3: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
17 weeks

Secondary outcomes

1

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.

Time frame
17 weeks
2

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.

Time frame
17 weeks
3

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.

Time frame
17 weeks
4

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.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Quantec Ltd

Lead sponsor

People Science, Inc.

Collaborator

Source ClinicalTrials.gov
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