actoferrin Supplementation, Immune Function & Respiratory Virus Infection in healthy, older adults: The LIFE Trial

Phase 2

Completed

• Conditions: Immune function; Respiratory virus infection; Inflammation; Inflammatory and Immune System - Normal development and function of the immune system; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12621001511820
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-05
• Study Completion: 2023-10-17
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

•Males and females aged 50 years of age or older
•Non-smokers (ceased smoking more than 6 months prior)

Exclusion Criteria

•Cow’s milk allergy (self-reported)
•Dietary or nutritional supplement use within the previous 4 weeks. If appropriate to do so, supplements that are not being taken for a health condition may be washed out for 2-4 weeks before commencing the trial
•Current smokers (smoked within previous 6 months)
•Maintenance use of systemic corticosteroid, immunosuppressive or antibiotic drugs
•Unstable cardiac, renal, hypertensive, pulmonary, endocrine, immunologic, neurologic disorders
•Acute or terminal illness, human immunodeficiency virus (HIV) or active cancer
•Any other medical condition which may interfere with the participant’s ability to participate in the intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ex-vivo production of Interferon-gamma by virus-infected PBMCs[ 4 weeks post initiation of treatment,]

Secondary Outcome Measures

Name	Time	Method
Ex-vivo production of IL-6 by virus-infected PBMCs[ 4 weeks post initiation of treatment];Peripheral blood immune cell analysis of immune cell subset numbers and percentages [ 4 weeks post initiation of treatment];Plasma IL-6[ 4 weeks post initiation of treatment];Ex-vivo production of interferon-lambda by virus-infected PBMCs[ 4 weeks post initiation of treatment];Plasma CRP[ 4 weeks post initiation of treatment];Plasma TNF-a[ 4 weeks post initiation of treatment];ex-vivo production of TNF-a by virus-infected PBMCs[ 4 weeks post initiation of treatment]