Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000646246
Ethics application status
Approved
Date submitted
28/07/2009
Date registered
30/07/2009
Date last updated
3/11/2020
Date data sharing statement initially provided
3/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The acute effects of a green tea extract, -Epigallocatechin Gallate (EGCG) on cognition, stress, brain function and cardiovascular function.
Scientific title
An investigation into the acute effects of
-Epigallocatechin Gallate (EGCG) on cognition, stress, brain function and cardiovascular function in healthy adults.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 237374 0
Relaxation and Stress 237375 0
Cardiovascular Function 237376 0
Brain Function 243414 0
Condition category
Condition code
Alternative and Complementary Medicine 239697 239697 0 0
Other alternative and complementary medicine
Mental Health 239715 239715 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 239716 239716 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 X 150mg Teavigo 'Registered Trademark' which is a caffeine free purified and refined extract of Camelia sinensis consisting of approximately 94% epigallo-catechin gallate (EGCG), and 6% Vitamin C (ascorbyl palmitate derived from corn dextrose fermentation and palm oil) and Hypo-allergenic plant fiber derived from pine cellulose.

Participants consume 2 X150mg oral capsules after baseline testing on one day only (to test the acute effects only).

Intervention and Placebo are administered in a randomised order with 1 week between treatments.
Intervention code [1] 237024 0
Behaviour
Intervention code [2] 237049 0
Prevention
Comparator / control treatment
2 X 150mg Avicel microcrystalline cellulose

Participants consume 2 X150mg oral capsules after baseline testing on one day only.

Intervention and Placebo are administered in a randomised order with 1 week between treatments.
Control group
Placebo

Outcomes
Primary outcome [1] 240467 0
Cognitive Function using Cognitive Drug Research (CDR) battery, Swinburne University Computerised Cognitive aging Battery (SUCCAB) battery
Timepoint [1] 240467 0
Baseline and 2 hours post dose
Secondary outcome [1] 245003 0
Stress/Relaxation using multitasking framework designed to induce stress and Electroencephalograph (EEG) recording
Timepoint [1] 245003 0
Baseline and 2 hours post dose
Secondary outcome [2] 257004 0
Cardiovascular Function using transcranial doppler ultrasound and sphygmocor system
Timepoint [2] 257004 0
Baseline and 2 hours post dose

Eligibility
Key inclusion criteria
- Healthy non smoking
- English speaking and right handed
- No history of anxiety, depression, epilepsy or psychiatric disorders
- Not taking any medications, for example anti-coagulants, anti-depressants, anti-cholinergics or acetycholinesterase inhibitors
- Not regularly taking any herbal extracts or vitamin supplements
- Not taking illicit drugs
- Possess no health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, celiac disease, peptic ulcers)
- Not pregnant or currently breast feeding
- Willing to participate in two 7 hour session in accordance to protocol
- Provide a signed and dated informed consent form
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Currently consume green tea on a daily basis
- Consume more than 3 standard alcoholic drinks per day
- Have a habitual caffeine intake exceeding 300mg (>3-4 cups of coffee per day)
- Smoker
- Have a known allergy to green tea and/or EGCG
- A history or diagnosis of hypotension, hypertension or heart disease
- A history of anxiety, depression, epilepsy or psychiatric disorders
- Currently taking any medications, herbal extracts, vitamin supplements or illicit drugs
- Any health conditions including celiac disease that would effect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, peptic ulcers)
- Pregnancy or breast feeding
- Current study participation in other trials involving investigational or marketed products

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 must first pass the phone screen and medical screen to ensure they are eligible for the trial and complete a practice day where they will be introduced to the cognitive tests. Participants will then be randomly allocated to receive either treatment A or B on their first testing day. A disinterested third party will generate the randomisation sequence using a computerised sequence generator. They will receive the other treatment on their second testing day
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will generate the randomisation sequence using a computerised sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2009
Actual
17/08/2009
Date of last participant enrolment
Anticipated
Actual
13/09/2009
Date of last data collection
Anticipated
Actual
21/09/2009
Sample size
Target
32
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237408 0
University
Name [1] 237408 0
Swinburne University
Country [1] 237408 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
400 Burwood rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 236905 0
None
Name [1] 236905 0
Address [1] 236905 0
Country [1] 236905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239539 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 239539 0
Ethics committee country [1] 239539 0
Australia
Date submitted for ethics approval [1] 239539 0
Approval date [1] 239539 0
10/07/2009
Ethics approval number [1] 239539 0
SUHREC 2009/050

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

Contacts
Principal investigator
Name 29975 0
Address 29975 0
Country 29975 0
Phone 29975 0
Fax 29975 0
Email 29975 0
Contact person for public queries
Name 13222 0
Marni Kras
Address 13222 0
400 Burwood Rd
Hawthorn VIC 3122
Country 13222 0
Australia
Phone 13222 0
613 9214 5094
Fax 13222 0
Email 13222 0
[email protected]
Contact person for scientific queries
Name 4150 0
Con Stough
Address 4150 0
400 Burwood Rd
Hawthorn VIC 3122
Country 4150 0
Australia
Phone 4150 0
613 9214 8167
Fax 4150 0
Email 4150 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.