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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crystal Haskell, Northumbria University
ClinicalTrials.gov Identifier:
NCT00981292
First received: September 21, 2009
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
Results First Received: June 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Cognitive Function
Mood
Interventions: Dietary Supplement: EGCG
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
135mg EGCG Then 0mg EGCG Then 270mg EGCG Those participants who received treatment in this order.
270mg EGCG Then 135mg EGCG Then 0mg EGCG Those participants who received treatment in this order.
0mg EGCG Then 135mg EGCG Then 270mg EGCG Those participants who received treatment in this order.
135mg EGCG Then 270mg EGCG Then 0mg EGCG Those participants who received treatment in this order.
0mg EGCG Then 270mg EGCG Then 135mg EGCG Those participants who received treatment in this order.
270mg EGCG Then 0mg EGCG Then 135mg EGCG Those participants who received treatment in this order.

Participant Flow for 3 periods

 Period 1:   Day 1
    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  
STARTED     7     4     6     4     4     7  
COMPLETED     6     4     6     4     4     5  
NOT COMPLETED     1     0     0     0     0     2  
Protocol Violation                 1                 0                 0                 0                 0                 2  

Period 2:   Day 2
    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  
STARTED     6     4     6     4     4     5  
COMPLETED     4     4     6     4     4     5  
NOT COMPLETED     2     0     0     0     0     0  
Protocol Violation                 2                 0                 0                 0                 0                 0  

Period 3:   Day 3
    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  
STARTED     4     4     6     4     4     5  
COMPLETED     4     4     6     4     4     4  
NOT COMPLETED     0     0     0     0     0     1  
Protocol Violation                 0                 0                 0                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
135mg EGCG Then 0mg EGCG Then 270mg EGCG Those participants who received treatment in this order.
270mg EGCG Then 135mg EGCG Then 0mg EGCG Those participants who received treatment in this order.
0mg EGCG Then 135mg EGCG Then 270mg EGCG Those participants who received treatment in this order.
135mg EGCG Then 270mg EGCG Then 0mg EGCG Those participants who received treatment in this order.
0mg EGCG Then 270mg EGCG Then 135mg EGCG Those participants who received treatment in this order.
270mg EGCG Then 0mg EGCG Then 135mg EGCG Those participants who received treatment in this order.
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
 		  7     4     6     4     4     7     32  
Age  
[units: participants]
 		             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     7     4     6     4     4     7     32  
>=65 years     0     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  22  ± 4     22  ± 4     22  ± 4     22  ± 4     22  ± 4     22  ± 4     22  ± 4  
Gender  
[units: participants]
 		             
Female     4     3     3     3     3     2     18  
Male     3     1     3     1     1     5     14  
Region of Enrollment  
[units: participants]
 		             
United Kingdom     7     4     6     4     4     7     32  



  Outcome Measures
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1.  Primary:   Modulation of Levels of Total Haemoglobin   [ Time Frame: 42 minutes ]

Measure Type Primary
Measure Title Modulation of Levels of Total Haemoglobin
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
135mg EGCG All participants when consumed 135mg EGCG.
270mg EGCG All participants when consumed 270mg EGCG.
Placebo All participants when consumed Placebo.

Measured Values
    135mg EGCG     270mg EGCG     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  27     27     27  
Modulation of Levels of Total Haemoglobin  
[units: μmol/L]
Mean ± Standard Error 		  -1.4  ± 0.5     -1.3  ± 0.3     -1.7  ± 0.3  


Statistical Analysis 1 for Modulation of Levels of Total Haemoglobin
Groups [1] 135mg EGCG
Method [2] ANOVA
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A Bonferroni adjustment was made for multiplicity.



2.  Secondary:   Number of Participants With Significant Modulation of Cognitive Performance   [ Time Frame: 42 minutes ]

Measure Type Secondary
Measure Title Number of Participants With Significant Modulation of Cognitive Performance
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis.

Reporting Groups
  Description
135mg All participants when consumed 135mg EGCG.
270mg EGCG All participants when consumed 270mg EGCG.
Placebo All participants when consumed Placebo.

Measured Values
    135mg     270mg EGCG     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  27     27     27  
Number of Participants With Significant Modulation of Cognitive Performance  
[units: Participants]
 		  0     0     0  


Statistical Analysis 1 for Number of Participants With Significant Modulation of Cognitive Performance
Groups [1] All groups
Method [2] ANCOVA
P Value [3] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Number of Participants With Significant Modulation of Mood.   [ Time Frame: 42 minutes ]

Measure Type Secondary
Measure Title Number of Participants With Significant Modulation of Mood.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis.

Reporting Groups
  Description
135mg EGCG All participants when consumed 135mg EGCG.
270mg EGCG All participants when consumed 270mg EGCG.
Placebo All participants when consumed Placebo.

Measured Values
    135mg EGCG     270mg EGCG     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  27     27     27  
Number of Participants With Significant Modulation of Mood.  
[units: Participants]
 		  0     0     0  


Statistical Analysis 1 for Number of Participants With Significant Modulation of Mood.
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Mood data was analysed via student t-test.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Emma Wightman
Organization: Northumbria university
phone: +44 (0) 191 2437253
e-mail: emma.l.wightman@unn.ac.uk


No publications provided


Responsible Party: Crystal Haskell, Northumbria University
ClinicalTrials.gov Identifier: NCT00981292     History of Changes
Other Study ID Numbers: 24Z1
Study First Received: September 21, 2009
Results First Received: June 25, 2010
Last Updated: March 20, 2012
Health Authority: United Kingdom: Research Ethics Committee