Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults
NCT ID: NCT00981292
Last Updated: 2012-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2009-08-31
2009-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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135mg EGCG
EGCG
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
Placebo
Pharmaceutical grade silica was utilized as placebo
270mg EGCG
EGCG
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
Placebo
Pharmaceutical grade silica was utilized as placebo
0mg EGCG
EGCG
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
Placebo
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.
Placebo
Pharmaceutical grade silica was utilized as placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Northumbria University
OTHER
Responsible Party
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Crystal Haskell
Research Fellow
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
Countries
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Other Identifiers
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24Z1
Identifier Type: -
Identifier Source: org_study_id
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