Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000140257
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
6/03/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a wild oat extract on cerebral blood flow, cognitive performance and psychological well-being in Australian adults.
Scientific title
Effects of Neuravena 'registered trade mark' (wild oat extract) on cerebral blood flow, blood pressure responses, cognitive performance and psychological well-being in Australian adults with mild cognitive impairment (MCI).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 4203 0
Condition category
Condition code
Mental Health 4413 4413 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 4414 4414 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will be required to consume two doses of Neuravena 'registered trade mark' (1500 or 2400 mg of Avena sativa extract (Neuravena 'registered trade mark' ). This supplement will be delivered orally in capsule form.
There will be three separate visits to the Nutritional Physiology Research Centre (of 1 - 2 hours duration each) which will occur with a minimum one-week washout between visits. At each visit the participant will consume one dose of Neuravena 'registered trade mark' (or placebo) per visit.
At 60 min after supplement consumption tests of short-term memory and working memory will be administered. This will be followed by the completion of a time-pressured cognitive test, the Paced Auditory Serial Addition Task (PASAT) and a subsequent carbon dioxide (CO2) challenge whilst assessing cerebral blood flow, heart rate and blood pressure. Participants will then complete the Depression Anxiety Stress Scale (DASS). These measures will be repeated at each visit.
Intervention code [1] 3952 0
Lifestyle
Comparator / control treatment
Placebo capsules are identical in appearance to the active capsules but contain an inert filler consisting of Calcium Hydrogen Phosphate, microcrystalline cellulose (MCC) of various particle sizes including Prosolv 50 and talcum powder (hydrated magnesium silicate).
There are a total of three testing visits for this trial. Two will include the consumption of a single dose of Neuravena® and one will be the placebo and each visit will be one week apart At 60 min after placebo consumption tests of short-term memory and working memory will be administered. This will be followed by the completion of a time-pressured cognitive test, the Paced Auditory Serial Addition Task (PASAT) and a subsequent carbon dioxide (CO2) challenge whilst assessing cerebral blood flow, heart rate and blood pressure. Participants will then complete the Depression Anxiety Stress Scale (DASS).
Control group
Placebo

Outcomes
Primary outcome [1] 5299 0
Degree of change in cerebral blood flow assessed by Transcranial Doppler (TCD) Sonography in the Middle Cerebral Artery (MCA).
Timepoint [1] 5299 0
There will be three time points which will occur one week apart. At each visit testing will commence 60 minutes after consumption of either Neuravena or placebo.
Primary outcome [2] 5300 0
Degree of change in performance on cognitive stress tasks assessed by administration of the Paced Auditory Serial Addition Task (PASAT)and the The Stroop test. Degree of changes in short-term memory, spatial memory and working memory tasks assessed by Digits Forwards, Digits Backwards and Letter-Number sequencing from the Wechsler Adults Intelligence Scale (WAIS-III) and the Spatial Span subscale from the Wechsler Memory Scale (WMS-III).
Timepoint [2] 5300 0
There will be three time points which will occur one week apart. At each visit testing will commence 60 minutes after consumption of either Neuravena or placebo.
Secondary outcome [1] 8967 0
Degree of change in psychological well-being assessed by administration of the Depression Anxiety Stress Scale (DASS).
Timepoint [1] 8967 0
There will be three time points which will occur one week apart. At each visit testing will commence 60 minutes after consumption of either Neuravena or placebo.

Eligibility
Key inclusion criteria
Men and Women aged over 50 years who are assessed as having mild cognitive impairment (MCI) but otherwise healthy. The degree of cognitive impairment will be determined at screening by a score in the range of 9-12 points on the Dem tect questionnaire.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Regular consumption of any form of cognitive enhancers, anticholinergic medication or mood medication during the trial.
History of serious head injury, diagnosed and/or treated mental illness, alcoholism, stroke and/or neurological condition.
Any other medical condition or treatments (including supplements) which, in the opinion of the investigators, may influence the outcome of 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)
Participants will be recruited from the general population by newspaper advertisements, flyers, electronic mail advertisements and radio/television announcements. Volunteers will be requested to attend the Nutritional Physiology Research Centre for a screening to assess their eligibility for the trial. Eligibility will be determined by the study coordinator. Volunteers will be required to consume each dose once, the order will be determined by a random number generator. Doses will be allocated a letter A-D for identification. The identity of the supplement will be held by an individual separate to the study and will not be decoded until all the data has been analysed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4387 0
Commercial sector/Industry
Name [1] 4387 0
Frutarom Switzerland Ltd
Country [1] 4387 0
Switzerland
Primary sponsor type
Individual
Name
Dr. Janet Bryan
Address
Nutritional Physiology Research Centre University of South Australia, PO Box 2471 Adelaide, South Australia, 5001.
Country
Australia
Secondary sponsor category [1] 3946 0
Individual
Name [1] 3946 0
Dr. Narelle Berry
Address [1] 3946 0
Nutritional Physiology Research Centre University of South Australia, PO Box 2471 Adelaide, South Australia, 5001.
Country [1] 3946 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6435 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 6435 0
General Purpose Building, Mawson Lakes Campus, Mawson Lakes Boulevard, Mawson Lakes, South Australia, 5095.
Ethics committee country [1] 6435 0
Australia
Date submitted for ethics approval [1] 6435 0
Approval date [1] 6435 0
18/12/2008
Ethics approval number [1] 6435 0
P238/08

Summary
Brief summary
Avena sativa (oats), in its various forms and extracts, has been traditionally known for its physical and psychological fortifying properties. Proposed beneficial effects include: reduced risk of heart disease, raised energy levels, increased ability to cope with stress, reduced anxiety and depression, and increased physical and cognitive performance.
The mechanism of effect is currently unknown. However, it has been suggested that green oat extract has a clinically significant inhibitory effect on monoamine oxidase B (MAO-B) and phosphodiesterase 4 (PDE4), effects which may improve cerebral vasodilation. As enhancement of cerebral blood flow by vasoactive nutrients has been hypothesised to improve cognitive function, this may be the mechanism by which oat extract could improve cognitive performance and stress response.
The aim of this study is to examine the short-term dose-response effects of Neuravena® on cognitive performance, on the ability to cope with stressful cognitive tasks and on psychological well-being (depression, anxiety, stress) and whether these effects are mediated by changes in cerebral blood flow.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35092 0
Address 35092 0
Country 35092 0
Phone 35092 0
Fax 35092 0
Email 35092 0
Contact person for public queries
Name 12439 0
Dr. Janet Bryan
Address 12439 0
Nutritional Physiology Research Centre University of South Australia, PO Box 2471 Adelaide, South Australia, 5001.
Country 12439 0
Australia
Phone 12439 0
+61 8 8302 2680
Fax 12439 0
Email 12439 0
[email protected]
Contact person for scientific queries
Name 3367 0
Dr. Janet Bryan
Address 3367 0
University of South Australia, Magill Campus, Magill, South Australia, 5072
Country 3367 0
Australia
Phone 3367 0
+61 8 8302 2680
Fax 3367 0
Email 3367 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

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