Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000228482
Ethics application status
Approved
Date submitted
24/04/2007
Date registered
1/05/2007
Date last updated
21/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The antioxidant and immunomodulatory effects of a Marinova seaweed extract on healthy individuals
Scientific title
Participant: Healthy individuals
Intervention: Seaweed extract
Comparator: Dose comparison
Outcome: In vivo changes in lymphocyte subsets and ex vivo changes in lymphocyte activation, phagocytosis of granulocytes and monocytes, and T helper1/T helper 2 cytokines.
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antioxidant and immune cell function 1759 0
Condition category
Condition code
Inflammatory and Immune System 1851 1851 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Seaweed extract taken from marine microalgae, Five of the participants will take two 500mg capsules of the study medication and five will take one 100mg capsule daily, with food. The study will continue for 28 days after the initial screening visit, measurement points will be at screening, day1, day 3 and week 4.
Intervention code [1] 1720 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 2592 0
In vivo changes in lymphocyte subsets and ex vivo changes in lymphocyte activation
Timepoint [1] 2592 0
Each outcome will be measured at: Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.
Primary outcome [2] 2593 0
In vivo changes in lymphocyte subsets and ex vivo changes in phagocytosis of granulocytes and monocytes
Timepoint [2] 2593 0
Each outcome will be measured at: Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.
Primary outcome [3] 2594 0
In vivo changes in lymphocyte subsets and ex vivo changes in T helper1/T helper 2 cytokines
Timepoint [3] 2594 0
Each outcome will be measured at: Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.
Secondary outcome [1] 4454 0
Ex vivo changes in serum oxygen radical absorbance capacity
Timepoint [1] 4454 0
Each outcome is measured at Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.

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
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals taking antioxidant medications and/or supplementsIndividuals with poor venous accessIndividuals with auto-immune disordersIndividuals taking steroid medication or NSAID (non steroidal anti inflammatory drugs)treatmentsIndividuals with diabetesIndividuals taking anticoagulantsIndividuals taking immune suppressant drugsIndividuals taking cytokine or interferon therapyIndividuals taking Echinacea or other immune stimulating herbsIndividuals with clinically abnormal liver function tests at baselineIndividuals who develop a cold or other acute URTI (upper respiratory tract infection) or influenza during the course of the studyIndividuals unwilling to have blood taken 4 times during the studyIndividuals unwilling to comply with the study protocolsIndividuals 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)
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
The participants will be blinded to the study dose
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 1998 0
Commercial sector/Industry
Name [1] 1998 0
Marinova Pty Ltd
Country [1] 1998 0
Primary sponsor type
Commercial sector/Industry
Name
Marinova Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 1809 0
None
Name [1] 1809 0
N/A
Address [1] 1809 0
Country [1] 1809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3705 0
NatMed-Research Department fo Natural and Complementary Medicine Southern Cross University
Ethics committee address [1] 3705 0
Lismore NSW
Ethics committee country [1] 3705 0
Australia
Date submitted for ethics approval [1] 3705 0
Approval date [1] 3705 0
16/04/2007
Ethics approval number [1] 3705 0
ECN-07-36

Summary
Brief summary
The purpose of the study is to determine the effects of a natural medicine formulation on antioxidant and immune cell function. The study hypothesises that the oral administration of the study medication over 4 weeks will result in a statistically significant lowering of fasting laboratory values of immune cell function, compared with baseline levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27823 0
Address 27823 0
Country 27823 0
Phone 27823 0
Fax 27823 0
Email 27823 0
Contact person for public queries
Name 10909 0
Dr Joan O'Connor
Address 10909 0
NatMed-Research
Department of Natural and Complementary Medicine
Southern Cross University
Military Road
Lismore NSW 2480
Country 10909 0
Australia
Phone 10909 0
+61 2 66203649
Fax 10909 0
+61 2 66203307
Email 10909 0
[email protected]
Contact person for scientific queries
Name 1837 0
Dr Joan O'Connor
Address 1837 0
NatMed-Research
Department of Natural and Complementary Medicine
Southern Cross University
Military Road
Lismore NSW 2480
Country 1837 0
Australia
Phone 1837 0
+61 2 66203649
Fax 1837 0
+61 2 66203307
Email 1837 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.