Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000498392
Ethics application status
Approved
Date submitted
1/07/2008
Date registered
30/09/2008
Date last updated
24/07/2020
Date data sharing statement initially provided
24/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of glucoregulatory processes in the cognition-enhancing effects of selected botanicals in healthy adults
Scientific title
The role of glucoregulatory processes in the cognition-enhancing effects of selected botanicals in healthy adults
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive function 3352 0
Condition category
Condition code
Alternative and Complementary Medicine 3507 3507 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study 1: The study will involve an oral administration of 3 Panax aquinquefolius doses (100mg, 200mg and 400mg)
On each testing day, participants will be randomly allocated to take a treatment once immediately after baseline assessment. Following a one week washout period each volunteer will return to the testing labs an undergo the same procedure under a different dose of Panax aquinquefolius until all treatments are complete.
Study 2: The methodology will be identical to that described in study 1, except three doses of Fraxinus excelsior (200mg, 400mg and 600mg) will be used.
Study 3: The methodology will be identical to that described in study 1, except three doses of Rosmarinus officinalis (250mg, 500mg and 750mg) will be used.
Study 4: The methodology will be identical to that described in study 1, except three doses of Spergularea purpurea (200mg, 400mg and 600mg) will be used.
Study 5: The methodology will be similar to the previous studies except that it will compare the optimal doses for cognitive enhancement identified in the preceding studies.
Intervention code [1] 3087 0
Prevention
Comparator / control treatment
Participants will take a placebo capsule containing maltidextrin immediately following baseline testing.
Control group
Placebo

Outcomes
Primary outcome [1] 4410 0
Cognitive function (working memory, secondary memory, attention and executive function) as measured by the Computerised Mental Performance Assessment (COMPASS)
Timepoint [1] 4410 0
Baseline and at 1, 3 and 6 hours post treatment administration
Primary outcome [2] 4411 0
Blood Glucose Levels
Timepoint [2] 4411 0
Baseline and at 1, 3 and 6 hours post treatment administration
Secondary outcome [1] 7441 0
Subjective mood measures using the Bond Lader Visual Analogue Scales
Timepoint [1] 7441 0
At baseline and at 1, 3 and 6 hours post treatment administration
Secondary outcome [2] 7442 0
Anxiety as measured by the State Trait Anxiety Inventory (STAI)
Timepoint [2] 7442 0
Baseline and at 1, 3 and 6 hours post treatment administration

Eligibility
Key inclusion criteria
non-smoker,
no history of anxiety, depression or psychiatric disorders
not taking medication (prescription or over the counter), herbal extracts, vitamin supplements or illicit drugs
no kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, celiac disease, peptic ulcers)
no health conditions affecting blood glucose levels - Diabetes (Type 1 & 2), hypoglycaemia, hyperglycaemia
no health conditions affecting the adrenal glands - Cushing's disease, Addison's disease
not pregnant or breast feeding.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoker
history of anxiety, depression or psychiatric disorders
taking any medication (prescription or over the counter), herbal extracts, vitamin supplements or illicit drugs
food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, celiac disease, peptic ulcers)
health conditions affecting blood glucose levels - Diabetes (Type 1 & 2), hypoglycaemia, hyperglycaemia
health conditions affecting the adrenal glands - Cushing's disease, Addison's disease
pregnant or breast feeding.

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)
Simple randomisation using latin square to ensure a fully counterbalanced design.

Allocation concealment via central randomisation (computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using latin square
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/06/2008
Actual
17/06/2008
Date of last participant enrolment
Anticipated
Actual
11/01/2010
Date of last data collection
Anticipated
Actual
12/03/2010
Sample size
Target
160
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3545 0
Commercial sector/Industry
Name [1] 3545 0
Naturex
Country [1] 3545 0
United States of America
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
HAWTHORN VIC 3122
Country
Australia
Secondary sponsor category [1] 3183 0
None
Name [1] 3183 0
Address [1] 3183 0
Country [1] 3183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5583 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 5583 0
Ethics committee country [1] 5583 0
Australia
Date submitted for ethics approval [1] 5583 0
Approval date [1] 5583 0
16/04/2008
Ethics approval number [1] 5583 0
SUHREC Project 0708/155

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

Contacts
Principal investigator
Name 28718 0
Address 28718 0
Country 28718 0
Phone 28718 0
Fax 28718 0
Email 28718 0
Contact person for public queries
Name 11875 0
Professor Andrew Scholey
Address 11875 0
Swinburne University of Technology
P O Box 218
HAWTHORN VIC 3122
Country 11875 0
Australia
Phone 11875 0
+ 61 39214 8932
Fax 11875 0
+ 61 39214 5525
Email 11875 0
[email protected]
Contact person for scientific queries
Name 2803 0
Professor Andrew Scholey
Address 2803 0
Swinburne University of Technology
P O Box 218
HAWTHORN VIC 3122
Country 2803 0
Australia
Phone 2803 0
+ 61 39214 8932
Fax 2803 0
+ 61 39214 5525
Email 2803 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.