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Completed

NCT Number: NCT00981292

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGCG

Dietary Supplement

Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.

Other names: Teavigo

Placebo

Dietary Supplement

Pharmaceutical grade silica was utilized as placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2009
Registry last updated
Apr 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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