Clinical Trials Directory

Trials / Completed

CompletedNCT00981292

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

Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Northumbria University · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTEGCGAcute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
DIETARY_SUPPLEMENTPlaceboPharmaceutical grade silica was utilized as placebo

Timeline

Start date
2009-08-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2009-09-22
Last updated
2012-04-13
Results posted
2012-04-13

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00981292. Inclusion in this directory is not an endorsement.