Trial registered on ANZCTR


Trial ID
ACTRN12605000258651
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
The antioxidant and immunomodulatory effects of Ambrotose AO in healthy smokers and non-smokers
Scientific title
The antioxidant and immunomodulatory effects of Ambrotose AO in healthy smokers and non-smokers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antioxidant activity and immune function 345 0
Condition category
Condition code
Inflammatory and Immune System 398 398 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ambrotose AO
Week 1 - Baseline 1;
Week 2 - Baseline 2;
Week 3 - 2 capsules daily;
Week 4 - 4 capsules daily
Week 5 - 8 capsules daily
Intervention code [1] 263 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 459 0
Ex vivo changes in serum oxygen radical capacity.
Timepoint [1] 459 0
Measured week 3, week 4, week 5, week 6.
Secondary outcome [1] 997 0
In vivo changes in lymphocyte subsets
Timepoint [1] 997 0
Measured weekly
Secondary outcome [2] 998 0
Urinary iPF2
Timepoint [2] 998 0
Measured weekly
Secondary outcome [3] 999 0
Phagocytosis of granulocytes and monocytes
Timepoint [3] 999 0
Measured weekly
Secondary outcome [4] 1000 0
COX 2 activity
Timepoint [4] 1000 0
Measured weekly

Eligibility
Key inclusion criteria
1. Individuals 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 taking antioxidant medications and/or supplements2. Individuals with poor venous access3. Individuals with auto-immune disorders4. Individuals with diabetes5. Individuals taking immune suppressant drugs6. Individuals taking cytokine or interferon therapy7. Individuals taking Echinacea or other immune stimulating herbs8. Individuals with clinically abnormal liver function tests at baseline9. Individuals unwilling to have blood taken 9 times during the study10. Individuals unwilling to comply with the study protocols11. Individuals with 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] 450 0
Commercial sector/Industry
Name [1] 450 0
Mannatech
Address [1] 450 0
Country [1] 450 0
Primary sponsor type
Commercial sector/Industry
Name
Mannatech
Address
Country
United States of America
Secondary sponsor category [1] 367 0
None
Name [1] 367 0
none
Address [1] 367 0
Country [1] 367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1424 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 1424 0
Ethics committee country [1] 1424 0
Australia
Date submitted for ethics approval [1] 1424 0
Approval date [1] 1424 0
Ethics approval number [1] 1424 0

Summary
Brief summary
The project was an open label, forced titration dose response study conducted over 5 weeks in 10 healthy smokers and 10 healthy non-smokers. Twenty-two subjects were enrolled in the study and were similarly treated with the study medication. Data was collected at baseline and then each week for a further 5 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35299 0
Address 35299 0
Country 35299 0
Phone 35299 0
Fax 35299 0
Email 35299 0
Contact person for public queries
Name 9452 0
Professor Stephen Myers
Address 9452 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9452 0
Australia
Phone 9452 0
+61 2 66203403
Fax 9452 0
+61 2 66203307
Email 9452 0
smyers@scu.edu.au
Contact person for scientific queries
Name 380 0
Joan O'Connor
Address 380 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 380 0
Australia
Phone 380 0
+61 2 66203649
Fax 380 0
+61 2 66203307
Email 380 0
joconnor@scu.edu.au