Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled study to evaluate the impact of bovine Lactoferrin (bLf) on respiratory tract infections (RTIs) in an elderly population in the United States.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Impact of Lactoferrin Dietary Supplementation on Respiratory Tract Infections in an Elderly Population

Conditions
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Immune Health

Intervention / Treatment
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* Dietary Supplement: Control: Placebo
* Dietary Supplement: bovine lactoferrin supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 55 years of age at time of consent Able to eat and drink, with assistance if required Investigator and Community Living Center administration expect subject to reside in Community Living Center for the duration of the study Signed consent obtained from subject or legally authorized representative Signed authorization obtained to use and/or disclose Protected Health Information Exclusion Criteria: Receiving (or, in the opinion of the Investigator, likely to receive in the next 6 months) parenteral nutrition Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation Has been diagnosed as immunocompromised or is receiving medication which may cause immune compromise. Note relative immunocompromisation due to age would not exclude the subject Known allergy or intolerance to study products On an end-of-life care pathway or, in the opinion of the Investigator, has a life expectancy of less than 6 months Inappropriate for inclusion in the study in the opinion of the Investigator or Community Living Center administration Have experienced Respiratory Tract Infection within 1 week prior to randomization

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control: Placebo<br>Control: Placebo | Dietary Supplement: Control: Placebo<br>* Placebo<br>|
| Experimental: Investigational: 600 mg bovine lactoferrin supplement<br>Investigational: 600 mg bovine lactoferrin supplement | Dietary Supplement: bovine lactoferrin supplement<br>* 600 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Respiratory Tract Infections |  | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Respiratory Tract Infection | Mild, Moderate, or Severe rating | 365 days | 
| Duration of Respiratory Tract Infection |  | 365 days | 
| Number of Respiratory Tract Infections |  | 180 days | 
| Treatment of Respiratory Tract Infections |  | 365 days | 
| Complications from Respiratory Tract Infections |  | 365 days | 
| Microorganism causing Respiratory Tract Infection |  | 365 days | 
| Level of protective antibody against influenza virus |  | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 | 
| Inflammatory cytokine |  | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 | 
| Protection against apoptosis and oxidative stress |  | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 | 
| Salivary level of lactoferrin |  | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 | 
| Salivary level of thiocyanate |  | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 | 
| Salivary level of hypohalous acid |  | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 | 
| Complete Blood Count |  | Baseline, Day 45, Day 90, Day 180, and Day 365 | 
| Comprehensive Metabolic Panel |  | Baseline, Day 45, Day 90, Day 180, and Day 365 | 
| Body Weight |  | Baseline, Day 45, Day 90, Day 180, and Day 365 | 
| Short Form (12) Health Survey Version 2 (SF-12v2®) |  | Baseline, Day 45, Day 90, Day 180, and Day 365 | 
| Use of medical treatments |  | 365 days | 
| Medically confirmed Adverse Events |  | 365 days | 
| COVID Vaccine specific inflammatory panel | IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines | Day 45, Day 90, Day 180, Day 270, and Day 365 | 
| Influenza Hemagglutination-inhibition Antibody Titer |  | Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28 | 
| Cytokine Panel |  | Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28 |