Bioavailability of bovine lactoferrin after a novel microencapsulation process and its effect on inflammatory markers and the gut microbiome in healthy males

INTERVENTION: A randomised, double‐blind, cross‐over trial. Each arm of the trial will last for 4 weeks, with a 2‐week washout period in between. The total trial period is 10 weeks. ‐ Two doses of Bovine Lactoferrin (BLf) will be tested, with and without modification ‐ Participants will receive modified Bovine Lactoferrin, or non‐modified BLf in a capsule. These capsules will be equivalent for BLf content. Those on the higher dose will simply take more of the capsules as a dose. Participants will be asked to take their required dose of capsules after breakfast each morning. ‐ Intervention will be delivered by an Advanced Accredited Practising Dieititian (AdvAPD). ‐ All participants will have fasting blood tests taken at baseline, 2 and 4 weeks after intervention commencement. ‐ Participants will attend face to face appointments at the School of Human Movement and Nutrition Sciences, University of Queensland at baseline, 2 weeks and 4 weeks after intervention commencement. This will be repeated on week 6 (after washout) and week 8 and 10. Note: week 6 pertains to baseline of the second arm; week 8 and week 10 pertains to week 2 and week 4 respectively. ‐ Intervention adherence will be assessed by collecting used lactoferrin supplement containers and supplement record forms from participants. CONDITION: General health promotion PRIMARY OUTCOME: Fecal lactoferrin levels ‐ measured using IBD‐scan kit (Techlab, inc.) Serum lactoferrin levels – measured using a serum lactoferrin ELISA (abcam) ; SECONDARY OUTCOME: Gut microbiome profile – analysis of fecal sample ‐ amplicon production, sequencing and community profiling Incidence of common viral infections (i.e. the common cold, influenza, gastroenteritis) ‐ measured by initial screening using total white cell counts, followed by self‐report of illness throughout the study. Quality of life scores – using the SF‐36 questionnaire ; Serum CD4+ and CD8+ counts ‐ using flow cytometric analysis INCLUSION CRITERIA: ‐ Healthy body weight (body mass index [BMI] 18.5‐24.9 kg/m2), not overweight or obese ‐ Available to participate for the required timeframe of the study (10 weeks) ‐ Not anaemic (i.e. Haemoglobin greater than or equal to 150 plus or minus 20g/L; Haematocrit greater than or equal to 0.45 plus or minus 0.05; red blood cell count greater than or equal to 5.0 plus or minus 0.5 x 1012/L) ‐ Non smoker