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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cognitive performance

Condition category

Condition code

Mental Health

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]

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]

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]

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]

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]

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]

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]

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]

Degree of change in cerebral blood flow assessed by Transcranial Doppler (TCD) Sonography in the Middle Cerebral Artery (MCA).

Timepoint [3]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5000-5999

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Frutarom Switzerland Ltd

Address [1]

Rutiwisstrasse 7
CH-8820 Wadenswil

Country [1]

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]

Individual

Name [1]

Dr Narelle Berry

Address [1]

Nutritional Physiology Research Centre, University of South Australia,
PO Box 2471,
Adelaide,
South Australia, 5001

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Prof Peter Howe

Address [2]

Nutritional Physiology Research Centre, University of South Australia,
PO Box 2471,
Adelaide,
South Australia, 5001

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

General Purpose Building,
Mawson Lakes Campus,
Mawson Lakes Boulevard,
Mawson Lakes, 5095
South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/01/2010

Ethics approval number [1]

P363/09

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 some ingredient(s) found in green oats have clinically significant inhibitory effects on monoamine oxidase B (MAO-B) and phosphodiesterase 4 (PDE4), effects which may improve cerebral vasodilatation. 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 effect of daily consumption of Neuravena for 12 weeks on the ability to cope with stressful cognitive tasks, cognitive performance and on psychological well-being (mood) and whether these effects are mediated by changes in cerebral blood flow.

Trial website

Trial related presentations / publications

Publications:
Wong RHX, Howe, P R C; Buckley, J D; Coates, A M; Berry, N M, Chronic consumption of a wild green oat extract (Neuravena 'Registered Trademark') improves brachial flow-mediated dilatation and cerebrovascular responsiveness in older adults. Journal of Hypertension, 2013, 31(1), 192-200.  

Rachel H. X. Wong, Peter R. C. Howe, Janet Bryan, Alison M. Coates, Jonathan D. Buckley and Narelle M. Berry, Chronic Effects of a Wild Green Oat Extract Supplementation on Cognitive Performance in Older Adults: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial, Nutrients 2012, 4(5), 331-342

Presentations:
1. RHX Wong, NM Berry, J Bryan, AM Coates, JD Buckley, PRC Howe, Effects of wild green oat extract (Neuravena 'Registered Trademark') on high demand cognitive performance and flow-mediated dilatation in older adults. Poster presented at the Nutritional Society of Australia and Nutritional Society of New Zealand Annual Scientific Meeting 2011, 30/11/2011, Queenstown, New Zealand.

2.Wong RHX, Berry NM, Buckley JD, Coates, AM, Howe, PRC, Sustained improvement in vasodilator function with regular wild green oat extract supplementation. Oral and poster presentation given at Australia Atherosclerosis Society Meeting September 2011, 14/09/2011, Adelaide, Australia 

3. RHX Wong, NM Berry, JD Buckley, AM Coates, PRC Howe, Regular consumption of a wild green oat extract enhances systemic and cerebral vasodilator function. Oral presentation given by PRC Howe at the High Blood Pressure Research Council of Australia Annual Scientific Meeting 2011, 05/12/2011, Perth, Australia.

Public notes

Contacts

Principal investigator

Name

Prof Peter Howe

Address

University of Newcastle
School of Biomedical Sciences & Pharmacy
Clinical Nutrition Research Centre
Callaghan, NSW 2308

Country

Australia

Phone

+61 02 4921 7309

Fax

peter.howe@newcastle.edu.au

Contact person for public queries

Name

Janet Bryan

Address

Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide,
South Australia, 5001.

Country

Australia

Phone

+61 8 83024385

Fax

janet.bryan@unisa.edu.au

Contact person for scientific queries

Name

Prof Peter Howe

Address

Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide,
South Australia, 5001.

Country

Australia

Phone

+61 8 83021200

Fax

+61 8 83022178

peter.howe@unisa.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

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