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

Study Overview
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Brief Summary
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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.

Official Title
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Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults

Conditions
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Cognitive Function, Mood

Intervention / Treatment
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* Dietary Supplement: EGCG
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 135mg EGCG<br> | Dietary Supplement: EGCG<br>* Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.<br>* Other names: Teavigo;Dietary Supplement: Placebo<br>* Pharmaceutical grade silica was utilized as placebo<br>|
| Active Comparator: 270mg EGCG<br> | Dietary Supplement: EGCG<br>* Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.<br>* Other names: Teavigo;Dietary Supplement: Placebo<br>* Pharmaceutical grade silica was utilized as placebo<br>|
| Placebo Comparator: 0mg EGCG<br> | Dietary Supplement: EGCG<br>* Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.<br>* Other names: Teavigo;Dietary Supplement: Placebo<br>* Pharmaceutical grade silica was utilized as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epigallocatechin Gallate, cerebral blood flow, Near Infrared spectroscopy, Electroencephalography, cognitive function, mood, cerebro-electrical activity