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

• Sponsor: Northumbria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00981292
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Function; Mood	Dietary Supplement: EGCG; Dietary Supplement: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northumbria University	Newcastle upon Tyne		United Kingdom	NE1 8ST

Sponsors and Collaborators

• Northumbria University

Investigators

• Principal Investigator: Crystal Haskell, Northumbria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Crystal Haskell, Research Fellow, Northumbria University
• ClinicalTrials.gov Identifier: NCT00981292
• Other Study ID Numbers: 24Z1
• First Posted: Sep 22, 2009
• Last Update Posted: Apr 13, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Crystal Haskell, Research Fellow, Northumbria University: Epigallocatechin Gallate; cerebral blood flow; Near Infrared spectroscopy; Electroencephalography; cognitive function; mood; cerebro-electrical activity

Study Results

Participant Flow

Arm/Group Title	135mg EGCG Then 0mg EGCG Then 270mg EGCG	270mg EGCG Then 135mg EGCG Then 0mg EGCG	0mg EGCG Then 135mg EGCG Then 270mg EGCG	135mg EGCG Then 270mg EGCG Then 0mg EGCG	0mg EGCG Then 270mg EGCG Then 135mg EGCG	270mg EGCG Then 0mg EGCG Then 135mg EGCG
Arm/Group Description	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.
Period Title: Day 1
STARTED	7	4	6	4	4	7
COMPLETED	6	4	6	4	4	5
NOT COMPLETED	1	0	0	0	0	2
Period Title: Day 1
STARTED	6	4	6	4	4	5
COMPLETED	4	4	6	4	4	5
NOT COMPLETED	2	0	0	0	0	0
Period Title: Day 1
STARTED	4	4	6	4	4	5
COMPLETED	4	4	6	4	4	4
NOT COMPLETED	0	0	0	0	0	1

Baseline Characteristics

Arm/Group Title	135mg EGCG Then 0mg EGCG Then 270mg EGCG	270mg EGCG Then 135mg EGCG Then 0mg EGCG	0mg EGCG Then 135mg EGCG Then 270mg EGCG	135mg EGCG Then 270mg EGCG Then 0mg EGCG	0mg EGCG Then 270mg EGCG Then 135mg EGCG	270mg EGCG Then 0mg EGCG Then 135mg EGCG	Total
Arm/Group Description	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Those participants who received treatment in this order.	Total of all reporting groups
Overall Participants	7	4	6	4	4	7	32
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	4 100%	6 100%	4 100%	4 100%	7 100%	32 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22 (4)	22 (4)	22 (4)	22 (4)	22 (4)	22 (4)	22 (4)
Sex: Female, Male (Count of Participants)
Female	4 57.1%	3 75%	3 50%	3 75%	3 75%	2 28.6%	18 56.3%
Male	3 42.9%	1 25%	3 50%	1 25%	1 25%	5 71.4%	14 43.8%
Region of Enrollment (participants) [Number]
United Kingdom	7 100%	4 100%	6 100%	4 100%	4 100%	7 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Modulation of Levels of Total Haemoglobin
Description	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.
Time Frame	42 minutes

Outcome Measure Data

Analysis Population Description

If NIRS readings were deemed not too affected by artefacts (usually caused by participants moving the headband in some way) then they were utilized in the analysis.

Arm/Group Title	135mg EGCG	270mg EGCG	Placebo
Arm/Group Description	All participants when consumed 135mg EGCG.	All participants when consumed 270mg EGCG.	All participants when consumed Placebo.
Measure Participants	27	27	27
Mean (Standard Error) [μmol/L]	-1.4 (0.5)	-1.3 (0.3)	-1.7 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	135mg EGCG
	Comments	This data was analysed by two-way repeated measures ANOVA (task [epoch] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	A Bonferroni adjustment was made for multiplicity.
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Number of Participants With Significant Modulation of Cognitive Performance
Description	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.
Time Frame	42 minutes

Outcome Measure Data

Analysis Population Description

If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis.

Arm/Group Title	135mg	270mg EGCG	Placebo
Arm/Group Description	All participants when consumed 135mg EGCG.	All participants when consumed 270mg EGCG.	All participants when consumed Placebo.
Measure Participants	27	27	27
Number [Participants]	0 (0) 0%	0 (0) 0%	0 (0) 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	135mg EGCG, 270mg EGCG, Placebo
	Comments	Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Number of Participants With Significant Modulation of Mood.
Description	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.
Time Frame	42 minutes

Outcome Measure Data

Analysis Population Description

As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis.

Arm/Group Title	135mg EGCG	270mg EGCG	Placebo
Arm/Group Description	All participants when consumed 135mg EGCG.	All participants when consumed 270mg EGCG.	All participants when consumed Placebo.
Measure Participants	27	27	27
Number [Participants]	0 (0) 0%	0 (0) 0%	0 (0) 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	135mg EGCG, 270mg EGCG, Placebo
	Comments	Mood data was analysed via student t-test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	135mg EGCG Then 0mg EGCG Then 270mg EGCG		270mg EGCG Then 135mg EGCG Then 0mg EGCG		0mg EGCG Then 135mg EGCG Then 270mg EGCG		135mg EGCG Then 270mg EGCG Then 0mg EGCG		0mg EGCG Then 270mg EGCG Then 135mg EGCG		270mg EGCG Then 0mg EGCG Then 135mg EGCG
Arm/Group Description	Those participants who received treatment in this order.		Those participants who received treatment in this order.		Those participants who received treatment in this order.		Those participants who received treatment in this order.		Those participants who received treatment in this order.		Those participants who received treatment in this order.
All Cause Mortality
	135mg EGCG Then 0mg EGCG Then 270mg EGCG		270mg EGCG Then 135mg EGCG Then 0mg EGCG		0mg EGCG Then 135mg EGCG Then 270mg EGCG		135mg EGCG Then 270mg EGCG Then 0mg EGCG		0mg EGCG Then 270mg EGCG Then 135mg EGCG		270mg EGCG Then 0mg EGCG Then 135mg EGCG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	135mg EGCG Then 0mg EGCG Then 270mg EGCG		270mg EGCG Then 135mg EGCG Then 0mg EGCG		0mg EGCG Then 135mg EGCG Then 270mg EGCG		135mg EGCG Then 270mg EGCG Then 0mg EGCG		0mg EGCG Then 270mg EGCG Then 135mg EGCG		270mg EGCG Then 0mg EGCG Then 135mg EGCG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/4 (0%)		0/6 (0%)		0/4 (0%)		0/4 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	135mg EGCG Then 0mg EGCG Then 270mg EGCG		270mg EGCG Then 135mg EGCG Then 0mg EGCG		0mg EGCG Then 135mg EGCG Then 270mg EGCG		135mg EGCG Then 270mg EGCG Then 0mg EGCG		0mg EGCG Then 270mg EGCG Then 135mg EGCG		270mg EGCG Then 0mg EGCG Then 135mg EGCG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/4 (0%)		0/6 (0%)		0/4 (0%)		0/4 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.