Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000613404
Ethics application status
Approved
Date submitted
27/11/2007
Date registered
28/11/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An Assessment of the Effects of a Nutritional Supplement Program on Healthy Aging
Scientific title
In patients with osteoarthritis of the knee does Ambrotose powder, Ambrotose AO, Phytomatrix and Plus 1, increase the quality of life and fatigue level?
Secondary ID [1] 500 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of life and fatigue in osteoarthritis of the knee 2588 0
Increases in quality of life and fatigue in individuals with osteoarthritis of the knee 2595 0
Condition category
Condition code
Alternative and Complementary Medicine 2706 2706 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ambrotose powder 1 teaspoon twice a day with food for 8 weeks
Ambrotose AO, 2 capsules twice a day with food for 8 weeks
Phytomatrix 1 capsule twice a day with food for 8 weeks
Plus 1 capsule twice a day with food for 8 weeks
Intervention code [1] 2320 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3597 0
Brief Fatigue Inventory.
Timepoint [1] 3597 0
Screening, Baseline (week 1), week 4, week 8 (end of study)
Primary outcome [2] 3598 0
COAT (Comprehensive Osteoarthritis Test) - This instrument consists of four items measured on 100mm visual analogue scale (VAS) response scales: joint pain, stiffness, difficulties with physical activities, and overall symptoms.
Timepoint [2] 3598 0
Screening, Baseline (week 1), week 4, week 8 (end of study)
Secondary outcome [1] 6021 0
Prospective Retrospective Memory Questionnaire
Timepoint [1] 6021 0
Screening, Baseline (week 1), week 4, week 8 (end of study)
Secondary outcome [2] 6022 0
Quality of Life Index Arthritis Version ? III
Timepoint [2] 6022 0
Screening, Baseline (week 1), week 4, week 8 (end of study)
Secondary outcome [3] 6023 0
Health Status Questionnaire 2.0
Timepoint [3] 6023 0
Screening, Baseline (week 1), week 4, week 8 (end of study)
Secondary outcome [4] 6024 0
Profile of Mood States
Timepoint [4] 6024 0
Screening, Baseline (week 1), week 4, week 8 (end of study)

Eligibility
Key inclusion criteria
Females and males, aged between 18 and 85 years
X-ray and clinical evidence of osteoarthritis of the knees
In good general health
Adequate venous access
Female participants of childbearing age who agree to continue using birth control measures for the duration of the study
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A history of trauma associated with the affected joint
Rheumatoid or other inflammatory joint conditions
Gout
Individuals with thyroid disorder
Individuals with diabetes
Individuals taking antidepressants
Individuals taking Warfarin of other anti-coagulant medication
Individuals who are lactose intolerant
Participants with a VAS score above 7 at baseline.
Participants who have just commenced on a treatment regimen for arthritis
Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the study
Liver function tests greater than 3 times the upper limit of normal at baseline
History of alcohol or substance abuse
History of allergy to iodine or shell fish
Female participants who are lactating, pregnant or planning to become pregnant
Participants who have participated in another clinical trial in the last 30 days
Participants unwilling to comply with the study protocol
Any other condition, which in the opinion of the investigators 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 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 500 0
2480

Funding & Sponsors
Funding source category [1] 2830 0
Other
Name [1] 2830 0
Mannatech Australia Pty Ltd
Country [1] 2830 0
Australia
Funding source category [2] 2831 0
Other
Name [2] 2831 0
Mannatech Australia Pty Ltd
Country [2] 2831 0
New Zealand
Funding source category [3] 2832 0
Commercial sector/Industry
Name [3] 2832 0
Mannatech Australia Pty Ltd
Country [3] 2832 0
Australia
Primary sponsor type
Other
Name
Mannatech Australia Pty Ltd
Address
Level 3 69 Christie Street St Leonards NSW 2064
Country
Australia
Secondary sponsor category [1] 2555 0
None
Name [1] 2555 0
Address [1] 2555 0
Country [1] 2555 0
Secondary sponsor category [2] 2556 0
None
Name [2] 2556 0
Address [2] 2556 0
Country [2] 2556 0
Other collaborator category [1] 95 0
University
Name [1] 95 0
NatMed-Research Southern Cross University
Address [1] 95 0
Southern Cross University Military Road Lismore NSW 2480
Country [1] 95 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4765 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 4765 0
Southern Cross University Military Road Lismore NSW 2480
Ethics committee country [1] 4765 0
Australia
Date submitted for ethics approval [1] 4765 0
17/09/2007
Approval date [1] 4765 0
05/10/2007
Ethics approval number [1] 4765 0
ECN-07-128

Summary
Brief summary
The purpose of the study is to determine the efficacy and safety of a Mannatech product in improving quality of life and reducing fatigue in participants with diagnosed osteoarthritis of the knee. Participants will take 4 Mannatech preperations twice a day with food for 8 weeks, they will attend a clinic at baseline, week 4 and week 8. At these times they will complete the study questionnaires. Blood wil be taken at baseline and week 8 to determine safety parameters.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28215 0
Address 28215 0
Country 28215 0
Phone 28215 0
Fax 28215 0
Email 28215 0
Contact person for public queries
Name 11372 0
Dr Joan O'Connor
Address 11372 0
NatMed-Research
Department fo Natural and Complementary Medicine, School of Health and Human Sciences, Southern Cross Universtiy.PO Box 157 Lismore NSW 2480
Country 11372 0
Australia
Phone 11372 0
02 66 20 3649
Fax 11372 0
01 66 20 3307
Email 11372 0
[email protected]
Contact person for scientific queries
Name 2300 0
Dr Joan O'Connor
Address 2300 0
NatMed-Research
Department fo Natural and Complementary Medicine, School of Health and Human Sciences, Southern Cross Universtiy.PO Box 157 Lismore NSW 2480
Country 2300 0
Australia
Phone 2300 0
02 66 20 3649
Fax 2300 0
01 66 20 3307
Email 2300 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.