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
PO Box 218
Hawthorn VIC 3122
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
It is believed that tea became a part of human culture around 5,000 years ago. Although health benefits have been attributed to tea consumption since the beginning of its history, scientific investigations of this beverage and its constituents have been underway for less than three decades (Pan et al., 2003).
Recent attention has focused on the potential neuroprotective effects of flavonoids (also known as catechins) which constitute approximately 30 to 40% of green tea. Epigallocatechin Gallate (EGCG) is the most abundant catechin found in green tea, and has proven to have a variety of physiological functions that accounts for its beneficial health effects. More specifically, EGCG has been implicated in the prevention and treatment of various cancers, treatment of skin cancers, and a reduction in heart disease as well as diabetes. The majority of research has also investigated green tea in relation to oral health, stress and anxiety management, weight management and various cardiovascular diseases. In addition, EGCG has been found to play a preventative role in neurodegenerative memory disorders such as Parkinson’s and Alzheimer’s disease.
Teavigo 'Registered Trademark' is a natural, caffeine-free, standardized extract from the leaves of the tea plant Camelia sinensis providing 94% ECGC. It is currently sold over the counter for its benefits in providing antioxidants, improving cardio-vascular and oral health, and assisting with weight management. However, to date, no study has investigated the acute biobehavioural effects of Teavigo 'Registered Trademark' as proposed in the current study.

The objective of the present study is to assess the acute affects of Teavigo 'Registered Trademark', on cognition, mood, cerebral blood flow and arterial stiffness, brain electrical activity and stress reactivity. This will be a randomised, double-blind placebo-controlled crossover study design involving a cohort of 32 healthy adult volunteers.

Participants will first come for a practice day where they will undergo a general health assessment followed by a practice session of the CDR Computerised Assessment Battery. One week later, participants will return for their testing day where they will undergo a series of assessments. These assessments will take place under two conditions: before treatment, then two hours after treatment. The assessments include: The CDR Computerised Assessment Battery, the SUCCAB and the Rapid Visual Information Processor (RVIP). Participants stress levels will be assessed by the Defined Intensity Stressor Simulation (DISS) computerised battery. Brain electrical activity will be recorded by EEG. Blood flow velocity will be measured by transcranial Doppler ultrasound, and aortic blood pressure and arterial stiffness will be assessed using the SphygmoCor. Participants’ mood will be measured via the Bond-Lader, stress visual analogue scales (VAS) and the State Trait Anxiety Inventory (STAI). Participants will then return for a third day where they will complete the exact same assessments as the first day except they will receive a different treatment.
The current study will provide a platform for further research on Teavigo 'Registered Trademark' and will allow a conclusion regarding the effects of acute consumption of Teavigo 'Registered Trademark' on the cognitive abilities, cardiovascular effects, brain electrical activity, mood and stress levels of healthy individuals.
Trial website
Trial related presentations / publications
Scholey A, Downey LA, Ciorciari J, et al. Acute neurocognitive effects of epigallocatechin gallate (EGCG). Appetite. 2012;58(2):767-770. doi:10.1016/j.appet.2011.11.016
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.