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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00981292
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Crystal Haskell, Northumbria University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cognitive Function Mood Dietary Supplement: EGCG Dietary Supplement: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults
Study Start Date : August 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 135mg EGCG Dietary Supplement: EGCG
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
Other Name: Teavigo

Dietary Supplement: Placebo
Pharmaceutical grade silica was utilized as placebo
Active Comparator: 270mg EGCG Dietary Supplement: EGCG
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
Other Name: Teavigo

Dietary Supplement: Placebo
Pharmaceutical grade silica was utilized as placebo
Placebo Comparator: 0mg EGCG Dietary Supplement: EGCG
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
Other Name: Teavigo

Dietary Supplement: Placebo
Pharmaceutical grade silica was utilized as placebo


Outcome Measures
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Primary Outcome Measures :
  1. Modulation of Levels of Total Haemoglobin [ Time Frame: 42 minutes ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Significant Modulation of Cognitive Performance [ Time Frame: 42 minutes ]
    The cognitive performance of participants was assessed via a range of computerised, mentally demanding, executive function tasks: Serial 3s and 7s subtractions, oddball reaction time task, rapid visual information processing, stroop and simple reaction time.These tasks were completed at baseline and then again 45 minutes after treatment administration. Significant modulation was determined if participants' post dose scores were significantly higher than baseline.

  2. Number of Participants With Significant Modulation of Mood. [ Time Frame: 42 minutes ]
    Mood was assessed via computerised visual analogue scales at baseline and post- dose time points. Mood scores were calculated as change from baseline. And significant modulation was determined if baseline scores were significantly different to post dose.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981292


Locations
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United Kingdom
Northumbria University
Newcastle upon Tyne, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
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Principal Investigator: Crystal Haskell Northumbria University
More Information
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Responsible Party: Crystal Haskell, Research Fellow, Northumbria University
ClinicalTrials.gov Identifier: NCT00981292    
Other Study ID Numbers: 24Z1
First Posted: September 22, 2009    Key Record Dates
Results First Posted: April 13, 2012
Last Update Posted: April 13, 2012
Last Verified: March 2012
Keywords provided by Crystal Haskell, Northumbria University:
Epigallocatechin Gallate
cerebral blood flow
Near Infrared spectroscopy
Electroencephalography
 cognitive function
mood
cerebro-electrical activity