Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000078358
Ethics application status
Approved
Date submitted
18/12/2006
Date registered
13/02/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An exploration of the antioxidant, immunomodulatory, and anti-inflammatory activities of Ambrotose in healthy individuals.
Scientific title
A randomised controlled study on Healthy Individuals to evaluate the efficacy of glyco-nutrient therapy compared to placebo on antioxidant and various immune cell functions with end of study outcomes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune system function in healthy individuals 2093 0
Antioxidant levels in healthy individuals 2809 0
Condition category
Condition code
Inflammatory and Immune System 2186 2186 0 0
Normal development and function of the immune system
Alternative and Complementary Medicine 2945 2945 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ambrotose AO Glyco-antioxidant Therapy. Two tablets were taken orally morning and night. The active medication contained 18 international units vitamin E, 113 mg Mannatech AO blend and 333mgs of Ambrotose Phyto Formula. The medication was taken for 5 weeks.
Intervention code [1] 2558 0
Treatment: Other
Comparator / control treatment
The trial is placebo controlled and the placebo is of the same excipient base as the active treatment and is identical in size, shape and colour. Two tablets were taken twice a day for 5 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 3035 0
Ex vivo changes in serum oxygen radical absorbance capacity.
Timepoint [1] 3035 0
Measured over an 8 week period at baseline (week -2) week 0, week 1, week 3 and week 5.
Secondary outcome [1] 5089 0
In vivo changes in lymphocyte subsets, lymphocyte activation, Phagocytosis of Granulocytes and Monocytes, and Cyclo oxygenase (COX 2) (anti inflammatory) activity. Participants had blood samples taken at weeks -2, 0, 1, 3 and 5 to measure these outcomes.
Timepoint [1] 5089 0
This was measured over an 8 week period at baseline (week -2) week 0, week 1, week 3 and week 5.

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
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals taking antioxidant medications and/or supplements. Individuals with poor venous access. Individuals with auto-immune disorders or an immune disease. Individuals taking steroid medication or non steroidal anti-inflammatory drugs (NSAID) treatments. Individuals with diabetes. Individuals taking anticoagulants. Individuals taking immune suppressant drugs. Individuals taking cytokine or interferon therapy. Individuals taking Echinacea or other immune stimulating herbs. Individuals with clinically abnormal liver function tests at baseline. Individuals who develop a cold or other acute upper respiratory tract infection (URTI) or influenza during the course of the study. Individuals unwilling to have blood taken 6 times during the study. Individuals unwilling to comply with the study protocols. 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A third party who is independant of the trial generated the random numbers by a computer software generated sequence program. The numbers were suplied to the person who decided if the participant was eligble for the study by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants involved in the study were blinded and study staff (therapists, assessors, clinicians and data analysists) were blinded.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 573 0
2480
Recruitment postcode(s) [2] 575 0
2480

Funding & Sponsors
Funding source category [1] 3075 0
Commercial sector/Industry
Name [1] 3075 0
Mannatech, Inc
Country [1] 3075 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mannatech, Inc
Address
600 S. Royal Lane, Suite 200
Coppell, TX 75019 USA
Country
United States of America
Secondary sponsor category [1] 2769 0
None
Name [1] 2769 0
Address [1] 2769 0
Country [1] 2769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5022 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 5022 0
Southern Cross University
PO Box 157 Lismore NSW
Ethics committee country [1] 5022 0
Australia
Date submitted for ethics approval [1] 5022 0
Approval date [1] 5022 0
04/07/2006
Ethics approval number [1] 5022 0
Ethics committee name [2] 5029 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [2] 5029 0
Southern Cross University
PO Box 157 Lismore NSW
Ethics committee country [2] 5029 0
Australia
Date submitted for ethics approval [2] 5029 0
Approval date [2] 5029 0
Ethics approval number [2] 5029 0

Summary
Brief summary
The study is a double blind, placebo controlled, randomised trial to be conducted over 6 weeks in parallel groups of otherwise healthy individuals. The study will compare baseline in vivo and ex vivo changes of antioxidant levels and various immune cell functions with end of study outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35854 0
Address 35854 0
Country 35854 0
Phone 35854 0
Fax 35854 0
Email 35854 0
Contact person for public queries
Name 10081 0
Professor Stephen Myers
Address 10081 0
NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480
Country 10081 0
Australia
Phone 10081 0
+61 2 66203403
Fax 10081 0
+61 2 66203307
Email 10081 0
smyers@scu.edu.au
Contact person for scientific queries
Name 1009 0
Dr Joan O'Connor
Address 1009 0
NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480
Country 1009 0
Australia
Phone 1009 0
+61 2 66203649
Fax 1009 0
+61 2 66203307
Email 1009 0
joconnor@scu.edu.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.