Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults
- Conditions
- Cognitive FunctionMood
- Interventions
- Dietary Supplement: EGCGDietary Supplement: Placebo
- Registration Number
- NCT00981292
- Lead Sponsor
- Northumbria University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- healthy
- aged 18-35
- either caffeine consumers (consume more than 150mg caffeine per day) or non-consumers (consume less than 44mg caffeine per day).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 135mg EGCG Placebo - 270mg EGCG Placebo - 135mg EGCG EGCG - 0mg EGCG EGCG - 0mg EGCG Placebo - 270mg EGCG EGCG -
- Primary Outcome Measures
Name Time Method Modulation of Levels of Total Haemoglobin 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
Name Time Method Number of Participants With Significant Modulation of Mood. 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.
Number of Participants With Significant Modulation of Cognitive Performance 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.
Trial Locations
- Locations (1)
Northumbria University
🇬🇧Newcastle upon Tyne, United Kingdom