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.

Study Overview

• Status: Completed
• Conditions: Immune Health
• Intervention / Treatment: Dietary supplement: Control: Placebo; Dietary supplement: bovine lactoferrin supplement

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control: Placebo	Dietary supplement: Control: Placebo; Placebo
Experimental: Investigational: 600 mg bovine lactoferrin supplement	Dietary supplement: bovine lactoferrin supplement; 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Investigators: Study Director: Steven Wu, MD, Mead Johnson/RB

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: 3393-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No