NCT00981292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 13, 2012

Completed
Last Updated

April 13, 2012

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

September 21, 2009

Results QC Date

June 25, 2010

Last Update Submit

March 20, 2012

Conditions

Cognitive FunctionMood

Keywords

Epigallocatechin Gallatecerebral blood flowNear Infrared spectroscopyElectroencephalographycognitive functionmoodcerebro-electrical activity

Outcome Measures

Primary Outcomes (1)

  • Modulation of Levels of Total Haemoglobin

    This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.

    42 minutes

Secondary Outcomes (2)

  • Number of Participants With Significant Modulation of Cognitive Performance

    42 minutes

  • Number of Participants With Significant Modulation of Mood.

    42 minutes

Study Arms (3)

135mg EGCG

ACTIVE COMPARATOR
Dietary Supplement: EGCGDietary Supplement: Placebo

270mg EGCG

ACTIVE COMPARATOR
Dietary Supplement: EGCGDietary Supplement: Placebo

0mg EGCG

PLACEBO COMPARATOR
Dietary Supplement: EGCGDietary Supplement: Placebo

Interventions

EGCGDIETARY_SUPPLEMENT

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

Also known as: Teavigo
0mg EGCG135mg EGCG270mg EGCG
PlaceboDIETARY_SUPPLEMENT

Pharmaceutical grade silica was utilized as placebo

0mg EGCG135mg EGCG270mg EGCG

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Results Point of Contact

Title
Emma Wightman
Organization
Northumbria university
emma.l.wightman@unn.ac.uk
+44 (0) 191 2437253

Study Officials

  • Crystal Haskell

    Northumbria University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 13, 2012

Results First Posted

April 13, 2012

Record last verified: 2012-03

Locations

GB(1)