Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000012077
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
6/01/2010
Date last updated
8/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a wild green oat extract enhance attention and concentration in adults under demanding conditions?
Scientific title
Effects of Neuravena 'registered trade
mark' (wild oat extract) on high demand cognitive performance, cerebral blood flow,
blood pressure responses, psychological well-being in healthy Australian adults aged over 60 years
Secondary ID [1] 1241 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 256469 0
Condition category
Condition code
Mental Health 256636 256636 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will consume a 1500mg dose of Avena sativa extract (Neuravena 'registered trade mark') daily for 12 weeks. This supplement will be delivered orally in capsule form. Subjects will have three separate visits to the Nutritional Physiology Research Centre (of 2 hours duration each). Following a baseline visit they will be randomised to consume a placebo or a 1500mg dose of Neuravena 'registered trade mark' for 12 weeks, after which they will cross over to the alternate treatment. The visits will 12 weeks apart. The time between the final measurement on the first supplement and first measurement after the crossover will be 12 weeks, this will serve as the washout period. At each visit resting supine clinic blood pressure will be measured following internationally recognised guidelines. This will be followed by measurement of cerebral blood flow during a carbon dioxide (CO2) challenge. Participants will then perform tests of attention, concentration, the ability to ignore distraction and to inhibit task-irrelevant information, namely the Stroop test, the Letter Cancellation task, the Rule Shift task, the Trail-Making test, the Dual Span Memory Task, and a multitasking Computerised Battery. Current mood will be assessed using Visual Analogue Scales, the mood states include: relaxed, alert, jittery, tired, tense, headache, mental fatigue and overall mood. These measures will be repeated at each visit.
Intervention code [1] 255753 0
Lifestyle
Comparator / control treatment
Placebo capsules (control treatment) 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). This supplement will be delivered orally in capsule form. Subjects will have three separate visits to the Nutritional Physiology Research Centre (of 2 hours duration each). Following a baseline visit they will be randomised to consume the control treatment or a 1500mg dose of Neuravena 'registered trade mark' for 12 weeks, after which they will cross over to the alternate treatment. The visits will be 12 weeks apart. At each visit resting supine clinic blood pressure will be measured following internationally recognised guidelines. This will be followed by measurement of cerebral blood flow during a carbon dioxide (CO2) challenge. Participants will then perform tests of attention, concentration, the ability to ignore distraction and to inhibit task-irrelevant information, namely the Stroop test, the Letter Cancellation task, the Rule Shift task, the Trail-Making test, the Dual Span Memory Task, and a multitasking Computerised Battery. Current mood will be assessed using Visual Analogue Scales, the mood states include: relaxed, alert, jittery, tired, tense, headache, mental fatigue and overall mood. These measures will be repeated at each visit.
Control group
Placebo

Outcomes
Primary outcome [1] 257527 0
The Stroop test.

This test requires participants to read the names of colours and then name the colours in which incongruent colour names are printed. The ratio between time taken to name colours compared with reading colour names reflects the degree of interference afforded by suppressing the habit of reading words in order to name colours. Uncorrected errors during the colour naming trial reflect failures of inhibition. Blood pressure responses to the Stroop test will be measured continuously using a Finapres 'registered trade mark' blood pressure monitor.
Timepoint [1] 257527 0
There will be a total of 3 timepoints. Baseline, week 12, then crossover to alternate dose (active or placebo), then an assessment at week 24.
Secondary outcome [1] 262757 0
Degree of change in performance on cognitive tasks assessed by administration of the Letter Cancellation task, the Rule Shift task, the Trail-Making test, the Dual Span Memory Task, and a multitasking Computerised Battery.
Timepoint [1] 262757 0
There will be a total of 3 timepoints. Baseline, week 12, then crossover to alternate dose (active or placebo), then an assessment at week 24.
Secondary outcome [2] 262758 0
Degree of change in mood assessed using Visual Analogue Scales, the mood states include: relaxed, alert, jittery, tired, tense, headache, mental fatigue and overall mood.
Timepoint [2] 262758 0
There will be a total of 3 timepoints. Baseline, week 12, then crossover to alternate dose (active or placebo), then an assessment at week 24.
Secondary outcome [3] 262788 0
Degree of change in cerebral blood flow assessed by Transcranial Doppler (TCD) Sonography in the Middle Cerebral Artery (MCA).
Timepoint [3] 262788 0
There will be a total of 3 timepoints. Baseline, week 12, then crossover to alternate dose (active or placebo), then an assessment at week 24.

Eligibility
Key inclusion criteria
Healthy men and women aged over 60 years
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking any form of cognitive enhancers, anticholinergic medication or mood medication during the trial, have a history of serious head injury, diagnosed and/or treated mental illness, alcoholism, stroke and/or neurological condition, suspected dementia as determined by Dem TECT (score less than 9), dyslexia, colourblindness, unable to perform transcranial Doppler assessment at baseline, cardiovascular, renal or gastrointestinal disease, diabetes, recent changes (last 3 months) in blood pressure (BP) lowering medication, resting supine blood pressure of >160/100 mmHg, regular consumption of oats (greater than one serve per day), smokers or those using nicotine replacement therapy will also be excluded, and 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
Prevention
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 screened via questionnaire to assess their eligibility for the trial. Eligibility will be determined by the study coordinator.

Volunteers will be required to consume each supplement (active or placebo) daily for 12 weeks, then crossed over to alternate dose, the order will be determined by a random number generator. Doses will be allocated a letter A or B 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
1/02/2010
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
30/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 2374 0
5000-5999

Funding & Sponsors
Funding source category [1] 256238 0
Commercial sector/Industry
Name [1] 256238 0
Frutarom Switzerland Ltd
Country [1] 256238 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] 251568 0
Individual
Name [1] 251568 0
Dr Narelle Berry
Address [1] 251568 0
Nutritional Physiology Research Centre, University of South Australia,
PO Box 2471,
Adelaide,
South Australia, 5001
Country [1] 251568 0
Australia
Secondary sponsor category [2] 251581 0
Individual
Name [2] 251581 0
Prof Peter Howe
Address [2] 251581 0
Nutritional Physiology Research Centre, University of South Australia,
PO Box 2471,
Adelaide,
South Australia, 5001
Country [2] 251581 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258329 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 258329 0
Ethics committee country [1] 258329 0
Australia
Date submitted for ethics approval [1] 258329 0
Approval date [1] 258329 0
15/01/2010
Ethics approval number [1] 258329 0
P363/09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30657 0
Prof Peter Howe
Address 30657 0
University of Newcastle
School of Biomedical Sciences & Pharmacy
Clinical Nutrition Research Centre
Callaghan, NSW 2308
Country 30657 0
Australia
Phone 30657 0
+61 02 4921 7309
Fax 30657 0
Email 30657 0
[email protected]
Contact person for public queries
Name 13904 0
Janet Bryan
Address 13904 0
Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide,
South Australia, 5001.
Country 13904 0
Australia
Phone 13904 0
+61 8 83024385
Fax 13904 0
Email 13904 0
[email protected]
Contact person for scientific queries
Name 4832 0
Prof Peter Howe
Address 4832 0
Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide,
South Australia, 5001.
Country 4832 0
Australia
Phone 4832 0
+61 8 83021200
Fax 4832 0
+61 8 83022178
Email 4832 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.