Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults
Condition: Cognitive Function; Mood
Intervention: EGCG; Placebo
Intervention description: Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.; Pharmaceutical grade silica was utilized as placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Epigallocatechin Gallate; cerebral blood flow; Near Infrared spectroscopy; Electroencephalography; cognitive function; mood; cerebro-electrical activity

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.
    

Eligibility criteria:

        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