Clinical trial NCT00981292: Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults
Official title: Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cognitive Function
Mood
Keywords: Epigallocatechin Gallate
cerebral blood flow
Near Infrared spectroscopy
Electroencephalography
cognitive function
mood
cerebro-electrical activity
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Modulation of Levels of Total Haemoglobin
timeFrame: 42 minutes
Secondary outcomes:
measure: Number of Participants With Significant Modulation of Cognitive Performance
timeFrame: 42 minutes
measure: Number of Participants With Significant Modulation of Mood.
timeFrame: 42 minutes
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Northumbria University
name: Crystal Haskell
role: PRINCIPAL_INVESTIGATOR
References: