Trial Outcomes & Findings for Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults (NCT NCT00981292)

Last Updated: 2012-04-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

42 minutes

Results posted on

2012-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Day 1 STARTED	7	4	6	4	4	7
Day 1 COMPLETED	6	4	6	4	4	5
Day 1 NOT COMPLETED	1	0	0	0	0	2
Day 2 STARTED	6	4	6	4	4	5
Day 2 COMPLETED	4	4	6	4	4	5
Day 2 NOT COMPLETED	2	0	0	0	0	0
Day 3 STARTED	4	4	6	4	4	5
Day 3 COMPLETED	4	4	6	4	4	4
Day 3 NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	135mg EGCG Then 0mg EGCG Then 270mg 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.
Day 1 Protocol Violation	1	2
Day 2 Protocol Violation	2	0
Day 3 Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	135mg EGCG Then 0mg EGCG Then 270mg EGCG n=7 Participants Those participants who received treatment in this order.	270mg EGCG Then 135mg EGCG Then 0mg EGCG n=4 Participants Those participants who received treatment in this order.	0mg EGCG Then 135mg EGCG Then 270mg EGCG n=6 Participants Those participants who received treatment in this order.	135mg EGCG Then 270mg EGCG Then 0mg EGCG n=4 Participants Those participants who received treatment in this order.	0mg EGCG Then 270mg EGCG Then 135mg EGCG n=4 Participants Those participants who received treatment in this order.	270mg EGCG Then 0mg EGCG Then 135mg EGCG n=7 Participants Those participants who received treatment in this order.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=10 Participants	32 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age Continuous	22 years STANDARD_DEVIATION 4 • n=5 Participants	22 years STANDARD_DEVIATION 4 • n=7 Participants	22 years STANDARD_DEVIATION 4 • n=5 Participants	22 years STANDARD_DEVIATION 4 • n=4 Participants	22 years STANDARD_DEVIATION 4 • n=21 Participants	22 years STANDARD_DEVIATION 4 • n=10 Participants	22 years STANDARD_DEVIATION 4 • n=115 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	18 Participants n=115 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	14 Participants n=115 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	7 participants n=10 Participants	32 participants n=115 Participants

PRIMARY outcome

Timeframe: 42 minutes

Population: 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.

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.

Outcome measures

Outcome measures
Measure	135mg EGCG n=27 Participants All participants when consumed 135mg EGCG.	270mg EGCG n=27 Participants All participants when consumed 270mg EGCG.	Placebo n=27 Participants All participants when consumed Placebo.
Modulation of Levels of Total Haemoglobin	-1.4 μmol/L Standard Error 0.5	-1.3 μmol/L Standard Error 0.3	-1.7 μmol/L Standard Error 0.3

SECONDARY outcome

Timeframe: 42 minutes

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

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.

Outcome measures

Outcome measures
Measure	135mg EGCG n=27 Participants All participants when consumed 135mg EGCG.	270mg EGCG n=27 Participants All participants when consumed 270mg EGCG.	Placebo n=27 Participants All participants when consumed Placebo.
Number of Participants With Significant Modulation of Cognitive Performance	0 Participants 0	0 Participants 0	0 Participants 0

SECONDARY outcome

Timeframe: 42 minutes

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

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.