Cognitive Function Clinical Trial
Official title:
Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults
Verified date | March 2012 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northumbria University | Newcastle upon Tyne |
Lead Sponsor | Collaborator |
---|---|
Northumbria University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Number of Participants With Significant Modulation of Cognitive Performance | 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. | 42 minutes | No |
Secondary | Number of Participants With Significant Modulation of Mood. | 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. | 42 minutes | No |
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