Trial registered on ANZCTR


Trial ID
ACTRN12605000255684
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
1/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
In vivo effects of a natural medicine formulation on human immune function
Scientific title
In vivo effects of a natural medicine formulation on human immune function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human immune function 342 0
Condition category
Condition code
Inflammatory and Immune System 395 395 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Beta-Glucan The subjects took 2 tablets daily one hour after breakfast. The first dose was taken on day 1 in the laboratory and the subject continued to take the medication for a further 13 days.
Intervention code [1] 259 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 452 0
Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Mature T Cells.
Timepoint [1] 452 0
Measured at baseline, baseline + 3 hours, day 13 and day 14
Primary outcome [2] 453 0
Ex vivo blood analysis included the assessment of changes in the lymphocyte subset B Cells.
Timepoint [2] 453 0
Measured at baseline, baseline + 3 hours, day 13 and day 14
Primary outcome [3] 454 0
Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Helper/Inducer T Cells.
Timepoint [3] 454 0
Measured at baseline, baseline + 3 hours, day 13 and day 14
Primary outcome [4] 455 0
Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Suppressor/Cytotoxic T Cells.
Timepoint [4] 455 0
Measured at baseline, baseline + 3 hours, day 13 and day 14
Primary outcome [5] 456 0
Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Natural Killer Cells.
Timepoint [5] 456 0
Measured at baseline, baseline + 3 hours, day 13 and day 14
Secondary outcome [1] 988 0
In vivo changes in the population of lymphocyte subsets.
Timepoint [1] 988 0
Measured at day -1, day 1, day1 + 3 hours, day 13 and day 14.

Eligibility
Key inclusion criteria
1. Subject is willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals with auto-immune disorders2. Individuals taking immune suppressant drugs3. Individuals taking cytokine or interferon therapy4. Individuals taking Echinacea or other immune stimulating herbs5. Individuals with clinically abnormal liver function tests at baseline6. Subjects unwilling to comply with the study protocols7. Subjects with poor venous access8. Any other condition which 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] 447 0
Commercial sector/Industry
Name [1] 447 0
Blackmores
Address [1] 447 0
Country [1] 447 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmores
Address
Country
Australia
Secondary sponsor category [1] 364 0
None
Name [1] 364 0
none
Address [1] 364 0
Country [1] 364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1420 0
Southern Cross university Human Research Ethics Committee
Ethics committee address [1] 1420 0
Ethics committee country [1] 1420 0
Australia
Date submitted for ethics approval [1] 1420 0
Approval date [1] 1420 0
Ethics approval number [1] 1420 0

Summary
Brief summary
Tablets were self administered by the participants for 14 days. Blood samples were drawn for laboratory analysis and safety measures (full blood count, liver function tests and serum urea, electrolytes and creatinine). Baseline blood was drawn for laboratory measures of study parameters at day 1, day1+3hours, day 13 and day 14. Blodd measured for Ex vivo blood tests Ex vivo blood analysis includes the assessment of changes in the following lymphocyte subsets:
ÿ¿ÿ· Mature T cells
ÿ¿ÿ· B cells
ÿ¿ÿ· Helper/Inducer T cells
ÿ¿ÿ· Suppressor/Cytotoxic T cells
ÿ¿ÿ· Natural killer cells

Assessment of changes in non-specific immune response includes:
ÿ¿ÿ· Phagocytosis of granulocytes
ÿ¿ÿ· Respiratory burst of granulocytes

Assessment of changes in specific immune response includes:
ÿ¿ÿ· Lymphocyte activation
ÿ¿ÿ· Production of the following 6 cytokines:
o IL-2, INFa and INFg for type 1 immune response
o IL-4, IL-5 and IL-10 for type 2 immune response
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35308 0
Address 35308 0
Country 35308 0
Phone 35308 0
Fax 35308 0
Email 35308 0
Contact person for public queries
Name 9448 0
Professor Stephen Myers
Address 9448 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9448 0
Australia
Phone 9448 0
+61 2 66203403
Fax 9448 0
+61 2 66203307
Email 9448 0
smyers@scu.edu.au
Contact person for scientific queries
Name 376 0
Joan O'Connor
Address 376 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 376 0
Australia
Phone 376 0
+61 2 66203649
Fax 376 0
+61 2 66203307
Email 376 0
joconnor@scu.edu.au