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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00981292
Other study ID # 24Z1
Secondary ID
Status Completed
Phase Phase 4
First received September 21, 2009
Last updated March 20, 2012
Start date August 2009
Est. completion date December 2009

Study information

Verified date March 2012
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
EGCG
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
Placebo
Pharmaceutical grade silica was utilized as placebo

Locations

Country Name City State
United Kingdom Northumbria University Newcastle upon Tyne

Sponsors (1)

Lead Sponsor Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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