Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001069448
Ethics application status
Approved
Date submitted
29/07/2016
Date registered
9/08/2016
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Bioavailability of bovine lactoferrin after a novel microencapsulation process and its effect on inflammatory markers and the gut microbiome in healthy males
Scientific title
Bioavailability of bovine lactoferrin after a novel microencapsulation process and its effect on inflammatory markers and the gut microbiome.
Secondary ID [1] 289783 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General health promotion
 300735 0
Condition category
Condition code
Inflammatory and Immune System 299615 299615 0 0
Normal development and function of the immune system
Diet and Nutrition 299616 299616 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295451 0
Treatment: Other
Comparator / control treatment
Participants may be allocated to one of two dosing orders, and to modified or non-modified lactoferrin capsules
Control group
Dose comparison

Outcomes
Primary outcome [1] 299085 0
Serum lactoferrin levels – measured using a serum lactoferrin ELISA (abcam)
Timepoint [1] 299085 0
Baseline, 2 and 4 weeks after intervention commencement.
Primary outcome [2] 299086 0
Fecal lactoferrin levels - measured using IBD-scan kit (Techlab, inc.)
Timepoint [2] 299086 0
Baseline, 2 and 4 weeks after intervention commencement.
Secondary outcome [1] 326104 0
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.
Timepoint [1] 326104 0
White cell counts: baseline, 2 and 4 weeks after intervention commencement
Self report of illness: baseline, 2 and 4 weeks after intervention commencement
Secondary outcome [2] 326107 0
Serum CD4+ and CD8+ counts - using flow cytometric analysis
Timepoint [2] 326107 0
Baseline, 2 and 4 weeks after intervention commencement.
Secondary outcome [3] 326108 0
Gut microbiome profile – analysis of fecal sample - amplicon production, sequencing and community profiling
Timepoint [3] 326108 0
Baseline and at 4 weeks after intervention commencement.
Secondary outcome [4] 326109 0
Quality of life scores – using the SF-36 questionnaire
Timepoint [4] 326109 0
Baseline and 4 weeks after intervention commencement.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Third party (A PhD scholar at the School of Human Movement and Nutrition Sciences, The University of Queensland, who is external to this research team) will perform the randomisation of treatment allocation and coding of products. Participants will be randomised to receive a particular dose (known to the randomiser but not the principal investigator through packaging differences), then randomised to the order of product presentation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomly allocated to dose using a permuted block randomisation design by an external party. Subjects will then be randomised to receive either the modified lactoferrin, or the non-modified lactoferrin for the first arm of the trial. They will then be given the other product for the crossover.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2016
Actual
11/08/2016
Date of last participant enrolment
Anticipated
12/08/2016
Actual
19/08/2016
Date of last data collection
Anticipated
20/10/2016
Actual
20/10/2016
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294167 0
Commercial sector/Industry
Name [1] 294167 0
UniQuest Pty Ltd
Country [1] 294167 0
Australia
Primary sponsor type
Individual
Name
Dr Olivia Wright
Address
School of Human Movement and Nutrition Sciences,
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 292999 0
None
Name [1] 292999 0
None
Address [1] 292999 0
None
Country [1] 292999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295575 0
Bellberry Limited
Ethics committee address [1] 295575 0
Ethics committee country [1] 295575 0
Australia
Date submitted for ethics approval [1] 295575 0
21/12/2015
Approval date [1] 295575 0
05/07/2016
Ethics approval number [1] 295575 0
2015-11-747

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67798 0
Dr Olivia Wright
Address 67798 0
The University of Queensland
School of Human Movement and Nutrition Sciences
Connell Building (26)
St Lucia QLD 4072
Country 67798 0
Australia
Phone 67798 0
+61 7 3365 6669
Fax 67798 0
(+61) 7 3365 6877
Email 67798 0
[email protected]
Contact person for public queries
Name 67799 0
Paul Stockwell
Address 67799 0
Level 7, General Purpose South
Staff House Road
The University of Queensland
Brisbane Qld 4072
Country 67799 0
Australia
Phone 67799 0
+61 (7) 3365 7476
Fax 67799 0
+61 (7) 3365-4433
Email 67799 0
[email protected]
Contact person for scientific queries
Name 67800 0
Gary Wilson
Address 67800 0
The University of Queensland
School of Human Movement and Nutrition Sciences
Connell Building (26)
St Lucia QLD 4072
Country 67800 0
Australia
Phone 67800 0
(+61) 7 3365 6445
Fax 67800 0
(+61) 7 3365 6877
Email 67800 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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