Immune Health
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTControl: Placebo
Placebo
DIETARY_SUPPLEMENTbovine lactoferrin supplement
600 mg
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Respiratory Tract Infections | 365 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Severity of Respiratory Tract Infection | 365 days | Mild, Moderate, or Severe rating |
| 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 | Day 45, Day 90, Day 180, Day 270, and Day 365 | IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines |
| 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 | — |
| Salivary level of hypohalous acid | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 | — |
Countries
United States
Outcome results
None listed