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

Not Applicable

Completed

• Conditions: General health promotion; Inflammatory and Immune System - Normal development and function of the immune system; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12616001069448
• Lead Sponsor: Dr Olivia Wright

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified