Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults

NCT ID: NCT00981292

Last Updated: 2012-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-12-31

Brief Summary

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Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large amount of research indicates EGCG (amongst other catechins) is responsible for most of the potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa \& Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects including modulation of cell survival and cell cycle genes (Levites et al 2002).

Although there have been several human studies looking at the bioavailability of EGCG when administered in varying doses, there have been no studies that have specifically investigated the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical activity (EEG) and behavioural effects of EGCG. A randomised, double-blind, placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day participants will attend a screening/training visit where relevant exclusion criteria will be assessed including any food sensitivities. They will also complete a caffeine consumption questionnaire in order to control for potential caffeine withdrawal effects as a result of restrictions of the study.

Detailed Description

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Conditions

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Cognitive Function Mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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135mg EGCG

Group Type ACTIVE_COMPARATOR

EGCG

Intervention Type DIETARY_SUPPLEMENT

Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Pharmaceutical grade silica was utilized as placebo

270mg EGCG

Group Type ACTIVE_COMPARATOR

EGCG

Intervention Type DIETARY_SUPPLEMENT

Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Pharmaceutical grade silica was utilized as placebo

0mg EGCG

Group Type PLACEBO_COMPARATOR

EGCG

Intervention Type DIETARY_SUPPLEMENT

Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Pharmaceutical grade silica was utilized as placebo

Interventions

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EGCG

Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Pharmaceutical grade silica was utilized as placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Teavigo

Eligibility Criteria

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Inclusion Criteria

* healthy
* aged 18-35
* either caffeine consumers (consume more than 150mg caffeine per day) or non-consumers (consume less than 44mg caffeine per day).

Exclusion Criteria

* smoke or consume any tobacco products
* not proficient in English language
* pregnant (or seeking to become pregnant)
* taking recreational, over the counter/prescription medication (including the contraceptive pill), and/or dietary/herbal supplements
* have food allergies or sensitivities
* have history of/current head trauma, learning difficulties , ADHD, migraines or any gastric problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Crystal Haskell

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Crystal Haskell

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

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Northumbria University

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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24Z1

Identifier Type: -

Identifier Source: org_study_id

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