None listed
Conditions
Brief summary
Lactoferrin is a well-known anti-viral and anti-bacterial protein that previous research has shown can improve immune function and reduce respiratory tract infections. Lactoferrin is made in the human body as part of our immune system defence and is normally present in saliva and breast milk. Lactoferrin is also naturally present in cow’s milk, allowing it to be purified and used as a dietary supplement. Clinical trials in adults and children show that lactoferrin supplements can reduce respiratory tract infections, though little research has been done to help us understand how lactoferrin improves immune function. The LIFE trial will test a lactoferrin dietary supplement in older adults, as immune function can decrease with older age. The LIFE trial will test whether taking a lactoferrin supplement, daily for 4 weeks can improve immune function and protect against virus infection in older adults. Researchers will do this by looking at changes in immune cells from blood samples taken before and after the 4-week trial.
Interventions
This is a randomised, double-blind, placebo-controlled, 4-week intervention trial, with 3 arms in parallel. The trial is testing a bovine lactoferrin supplement, with healthy, older adults randomly assigned to either high or low dose bovine lactoferrin or placebo for 4 weeks.
Bovine lactoferrin is a protein found in cow’s milk which has been shown to modulate the immune system and reduce systemic inflammation. This trial will assess the efficacy of both high dose and low dose bovine lactoferri
This is a randomised, double-blind, placebo-controlled, 4-week intervention trial, with 3 arms in parallel. The trial is testing a bovine lactoferrin supplement, with healthy, older adults randomly assigned to either high or low dose bovine lactoferrin or placebo for 4 weeks. Bovine lactoferrin is a protein found in cow’s milk which has been shown to modulate the immune system and reduce systemic inflammation. This trial will assess the efficacy of both high dose and low dose bovine lactoferrin supplementation in improving immune function, by measuring cytokine release from virus-infected peripheral blood mononuclear cells (PBMCs). The effect of bovine lactoferrin on peripheral immune cell profiles and systemic inflammation will also be examined. All participants will be randomised at the baseline visit, to receive a 4-week intervention with either: Arm 1: High dose bovine lactoferrin 600mg/d capsule or Arm 2: Low dose bovine lactoferrin 200mg/d capsule or Arm 3: Placebo control (Microcrystalline cellulose) capsule Participants will be instructed to consume 1 capsule per day with water, in the morning, before food. For the duration of the trial, participants will complete a trial diary entry each day to record compliance with the intervention, any illnesses, and adverse effects. The trial will be conducted at the Hunter Medical Research Institute, by the University of Newcastle. Participants will attend the Clinical Trials Facility on Level 4 at the Hunter Medical Research Institute (HMRI) for a 1 hour visit, after a 12-hour overnight fast before and after the 4 week intervention, for a total of two trial visits. Height, body weight and blood pressure will be measured. A venous blood sample will be collected via venepuncture by trained personnel. Medical history and medication use will be recorded. Participants will also be asked to complete a food frequency questionnaire to assess usual dietary intake, and a 24-hour food recall with frequency checklist will be collected to assess recent dietary intake. Participants will also complete a health-related quality of life questionnaire (HRQOL-14). Participants will be contacted by telephone at week 2 for motivational purposes, to collect information on compliance with the intervention and to establish whether any adverse events or illness have been experienced. The telephone call will be approximately 15 minutes in duration. Compliance with the intervention will be monitored and assessed using the trial diary and pill countback of remaining trial supplement capsules at V2. Participants will be asked to complete the diary each day by recording consumption of the trial supplement.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Outcome results
None listed