CompletedPhase 3Phase 4ACTRN12609000646246

The acute effects of a green tea extract, -Epigallocatechin Gallate (EGCG) on cognition, stress, brain function and cardiovascular function.

An investigation into the acute effects of -Epigallocatechin Gallate (EGCG) on cognition, stress, brain function and cardiovascular function in healthy adults.


Sponsor

Swinburne University

Enrollment

32 participants

Start Date

Aug 17, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a green tea extract (EGCG) can improve mental performance, reduce stress, and benefit heart function in healthy people. It is for healthy, non-smoking, right-handed adults aged 18 to 60 who speak English. People who take medications, have food allergies, drink green tea daily, or have a history of mental health conditions are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 (a

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.


Locations(1)

Australia

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ACTRN12609000646246


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