Text Size

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
  Hide Participant Flow

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
  Show Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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