Trial registered on ANZCTR


Trial ID
ACTRN12605000289617
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
5/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An exploration of the immunomodulatory, anti-inflammatory and antioxidant activities of bovine lactoferrin in healthy males (a pilot study)
Scientific title
An exploration of the immunomodulatory, anti-inflammatory and antioxidant activities of bovine lactoferrin in healthy males (a pilot study)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune system 377 0
Condition category
Condition code
Inflammatory and Immune System 447 447 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Day 8-14 100mg bovine lactoferrin 100mg calcium phosphate with excipient magnesium stearate Day 15-21 200mg bovine lactoferrin with excipient magnesium stearate.
Intervention code [1] 271 0
Treatment: Other
Comparator / control treatment
Day 1-7 Placebo containing 200mg calcium phosphate with excipient magnesium stearate
Control group
Uncontrolled

Outcomes
Primary outcome [1] 505 0
In vivo changes in Lymphocyte Subset Counts including Mature T Cells (CD3+), B Cells (CD19+)
Timepoint [1] 505 0
Days 1, 8, 10, 15, 17, 22
Primary outcome [2] 506 0
In vivo changes in Lymphocyte Subset Counts including Helper T cells (CD3+CD4+)
Timepoint [2] 506 0
Days 1, 8, 10, 15, 17, 22
Primary outcome [3] 507 0
In vivo changes in Lymphocyte Subset Counts including Cytotoxic T Cells (CD3+CD8+)
Timepoint [3] 507 0
Days 1, 8, 10, 15, 17, 22
Primary outcome [4] 508 0
In vivo changes in Lymphocyte Subset Counts including Natural Killer Cells (CD3-CD16+and/orCD56+)
Timepoint [4] 508 0
Days 1, 8, 10, 15, 17, 22
Primary outcome [5] 509 0
In vivo changes in Non-Specific Immune Response including Natural Killer cell cytotoxicity
Timepoint [5] 509 0
Days 1, 8, 10, 15, 17, 22
Secondary outcome [1] 1092 0
In vivo changes in Specific Immune Response including:
* Activation of T-lymphocytes (CD4 and CD8)
* Production of the following six cytokines:
* IL-2, TNFá and IFNã predominantly regulating cell-mediated immune response
* IL-4, IL-6 and IL-10 predominantly regulating humoral immune response
Timepoint [1] 1092 0
All measured weekly during the study.
Secondary outcome [2] 1093 0
In vivo changes in Serum oxygen radical antioxidant capacity (ORAC).
Timepoint [2] 1093 0
All measured weekly during the study.

Eligibility
Key inclusion criteria
Individuals willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Minimum age
30 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Individual taking antioxidant medications and /or supplements. Individuals with poor venous access. Individuals with auto-immune disorders. Individuals with diabetes. Individuals taking immune suppressant drugsÃ. Individuals taking cytokine or interferon therapy. Individuals taking Echinacea or other immune stimulating herbs. Individuals who smoke cigarettes or any other drug. Individuals with clinically abnormal liver function tests at baseline. Individuals unwilling to have blood taken 7 times during the study. Individuals unwilling to comply with the study protocols. Individuals with any other condition that in the opinion of the researchers could compromise the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 497 0
Commercial sector/Industry
Name [1] 497 0
Blackmores
Address [1] 497 0
Country [1] 497 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmores
Address
Country
Australia
Secondary sponsor category [1] 406 0
None
Name [1] 406 0
none
Address [1] 406 0
Country [1] 406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1474 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 1474 0
Ethics committee country [1] 1474 0
Australia
Date submitted for ethics approval [1] 1474 0
Approval date [1] 1474 0
Ethics approval number [1] 1474 0
Ethics committee name [2] 1475 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 1475 0
Ethics committee country [2] 1475 0
Australia
Date submitted for ethics approval [2] 1475 0
Approval date [2] 1475 0
Ethics approval number [2] 1475 0

Summary
Brief summary
The study explored the degree of safety and efficacy of a bovine lactoferrin supplement on healthy males by evaluating the in vivo and ex vivo changes of antioxidant and various immune cell functions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35324 0
Address 35324 0
Country 35324 0
Phone 35324 0
Fax 35324 0
Email 35324 0
Contact person for public queries
Name 9460 0
Professor Stephen Myers
Address 9460 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9460 0
Australia
Phone 9460 0
+61 2 66203403
Fax 9460 0
+61 2 66203307
Email 9460 0
smyers@scu.edu.au
Contact person for scientific queries
Name 388 0
Joan O'Connor
Address 388 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 388 0
Australia
Phone 388 0
+61 2 66203649
Fax 388 0
+61 2 66203307
Email 388 0
joconnor@scu.edu.au