Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 135mg EGCG | Active Comparator |
| |
| 270mg EGCG | Active Comparator |
| |
| 0mg EGCG | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGCG | Dietary Supplement | Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Crystal Haskell | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University | Newcastle upon Tyne | NE1 8ST | United Kingdom |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 135mg EGCG Then 0mg EGCG Then 270mg EGCG | Those participants who received treatment in this order. |
| FG001 | 270mg EGCG Then 135mg EGCG Then 0mg EGCG | Those participants who received treatment in this order. |
| FG002 | 0mg EGCG Then 135mg EGCG Then 270mg EGCG | Those participants who received treatment in this order. |
| FG003 | 135mg EGCG Then 270mg EGCG Then 0mg EGCG | Those participants who received treatment in this order. |
| FG004 | 0mg EGCG Then 270mg EGCG Then 135mg EGCG | Those participants who received treatment in this order. |
| FG005 | 270mg EGCG Then 0mg EGCG Then 135mg EGCG | Those participants who received treatment in this order. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 |
|
| ||||||||||||||||||
| Day 2 |
| |||||||||||||||||||
| Day 3 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 135mg EGCG Then 0mg EGCG Then 270mg EGCG | Those participants who received treatment in this order. |
| BG001 | 270mg EGCG Then 135mg EGCG Then 0mg EGCG | Those participants who received treatment in this order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | μmol/L | 42 minutes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 135mg EGCG Then 0mg EGCG Then 270mg EGCG | Those participants who received treatment in this order. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emma Wightman | Northumbria university | +44 (0) 191 2437253 | emma.l.wightman@unn.ac.uk |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Dietary Supplement | Pharmaceutical grade silica was utilized as placebo |
|
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | 0mg EGCG Then 135mg EGCG Then 270mg EGCG | Those participants who received treatment in this order. |
| BG003 | 135mg EGCG Then 270mg EGCG Then 0mg EGCG | Those participants who received treatment in this order. |
| BG004 | 0mg EGCG Then 270mg EGCG Then 135mg EGCG | Those participants who received treatment in this order. |
| BG005 | 270mg EGCG Then 0mg EGCG Then 135mg EGCG | Those participants who received treatment in this order. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Placebo |
All participants when consumed Placebo. |
|
|
|
| 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. | If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis. | Posted | Number | Participants | 42 minutes |
|
|
|
|
| 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. | As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis. | Posted | Number | Participants | 42 minutes |
|
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 270mg EGCG Then 135mg EGCG Then 0mg EGCG | Those participants who received treatment in this order. | 0 | 4 | 0 | 4 |
| EG002 | 0mg EGCG Then 135mg EGCG Then 270mg EGCG | Those participants who received treatment in this order. | 0 | 6 | 0 | 6 |
| EG003 | 135mg EGCG Then 270mg EGCG Then 0mg EGCG | Those participants who received treatment in this order. | 0 | 4 | 0 | 4 |
| EG004 | 0mg EGCG Then 270mg EGCG Then 135mg EGCG | Those participants who received treatment in this order. | 0 | 4 | 0 | 4 |
| EG005 | 270mg EGCG Then 0mg EGCG Then 135mg EGCG | Those participants who received treatment in this order. | 0 | 7 | 0 | 7 |
Not provided
Not provided