ANZCTR - Registration

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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

Relaxation and Stress

Cardiovascular Function

Brain Function

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Mental Health

Studies of normal psychology, cognitive function and behaviour

Cardiovascular

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]

Behaviour

Intervention code [2]

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]

Cognitive Function using Cognitive Drug Research (CDR) battery, Swinburne University Computerised Cognitive aging Battery (SUCCAB) battery

Timepoint [1]

Baseline and 2 hours post dose

Secondary outcome [1]

Stress/Relaxation using multitasking framework designed to induce stress and Electroencephalograph (EEG) recording

Timepoint [1]

Baseline and 2 hours post dose

Secondary outcome [2]

Cardiovascular Function using transcranial doppler ultrasound and sphygmocor system

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Swinburne University

Address [1]

400 Burwood rd
Hawthorn VIC 3122

Country [1]

Australia

Primary sponsor type

University

Name

Swinburne University

Address

400 Burwood rd
Hawthorn VIC 3122

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne University Human Research Ethics Committee

Ethics committee address [1]

PO Box 218 
Hawthorn VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/07/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Marni Kras

Address

400 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Phone

613 9214 5094

Fax

nutra@swin.edu.au

Contact person for scientific queries

Name

Con Stough

Address

400 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Phone

613 9214 8167

Fax

cstough@swin.edu.au

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.

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