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

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

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.

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