None listed
Conditions
Brief summary
Lactoferrin is a protein involved in protection against microbial infections and the prevention of systemic inflammation, and is found in milk, saliva and other secretions. The study is designed to measure how well the lactoferrin absorbs into the digestive system, compared to a modified lactoferrin product. We will also be looking at how well the immune system is functioning before and after taking the lactoferrin/modified lactoferrin product. The purpose of the study is to improve understanding of the absorption and efficacy of bovine lactoferrin with a view to the creation of new functional food products in the future.
Interventions
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
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.
Sponsors
Dr Olivia Wright
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Exclusion criteria
- Any allergy or intolerance to dairy products - BMI <18.5 or >24.9 kg/m2 - Current consumption of lactoferrin-fortified products or lactoferrin supplements - Inability to provide informed consent due to diminished understanding or comprehension, or a language other than English spoken and an interpreter unavailable -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) -Taking any form of recreational drug -Taking immunosuppressives (i.e. corticosteroids such as prednisone; monoclonal antibodies including basiliximab, daclizumab and muromonab; cyclosporine or azathioprine; tacrolimus; sirolimus; mycophenolate mofetil; other cytotoxic drugs, e.g. methotrexate, chlorambucil) or any other immunomodulating drugs or analogues (i.e. levamisole, immune globulin, thymic factors, cytokines, thalidomide, lenalidomide, Revlimid, Actimid, pomalidomide and apremilast). -Current viral infection (without reference to serology) -Consuming >2 standard drinks on any day (i.e. alcohol consumption beyond the national guidelines) -Smokers, including those in the process of quitting – i.e. using e-cigs and nicotine patches
Outcome results
None listed