Trial Outcomes & Findings for The Cognitive and Cerebral Blood Flow Effects of Resveratrol (NCT NCT01010009)

Results Overview

This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)

Results posted on

2012-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Resveratrol 250mg Then Resveratrol 500mg Then Placebo	Resveratrol 500mg Then Placebo Then Resveratrol 250mg	Placebo Then Resveratrol 250mg Then Resveratrol 500mg
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	8	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Cognitive and Cerebral Blood Flow Effects of Resveratrol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resveratrol 250mg Then Resveratrol 500mg Then Placebo n=8 Participants	Resveratrol 500mg Then Placebo Then Resveratrol 250mg n=8 Participants	Placebo Then Resveratrol 250mg Then Resveratrol 500mg n=8 Participants	Total n=24 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
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 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
Age Continuous	19.2 years STANDARD_DEVIATION 2.2 • n=5 Participants	21.3 years STANDARD_DEVIATION 1.8 • n=7 Participants	20 years STANDARD_DEVIATION 2 • n=5 Participants	20 years STANDARD_DEVIATION 2 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants

PRIMARY outcome

Timeframe: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)

Population: NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.

This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).

Outcome measures

Outcome measures
Measure	Resveratrol 250mg n=22 Participants	Resveratrol 500mg n=22 Participants	Placebo n=22 Participants
Modulation of Levels of Total Haemoglobin	1.9 µmol/L Standard Error 0.9	2.4 µmol/L Standard Error 0.8	1.2 µmol/L Standard Error 0.1

PRIMARY outcome

Timeframe: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)

Population: NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.

This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).

Outcome measures

Outcome measures
Measure	Resveratrol 250mg n=22 Participants	Resveratrol 500mg n=22 Participants	Placebo n=22 Participants
Modulation of Deoxygenated Levels of Haemoglobin	0.4 µmol/L Standard Error 0.2	0.2 µmol/L Standard Error 0.11	-0.2 µmol/L Standard Error 0.1

SECONDARY outcome

Timeframe: 46-81 mins post dose

Population: Cognitive performance data was analysed for all subjects who completed the trial. If data was not utilized in the final analysis then this was either due to technical issues (i.e. the computer did not save data) or it was clear that the participant had not engaged with the task/s.

This outcome measure assessed any significant modulation of cognitive task performance during the 46-81 min post dose period. The cognitive tasks utilized were cognitively demanding computer based, numerical tasks which assessed working memory. Significant modulation is defined as significant difference between baseline and post-dose task performance.

Outcome measures

Outcome measures
Measure	Resveratrol 250mg n=22 Participants	Resveratrol 500mg n=22 Participants	Placebo n=22 Participants
Number of Participants With Significant Modulation of Cognitive Performance	0 Participants 0	0 Participants 0	0 Participants 0

Adverse Events

Resveratrol 250mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Resveratrol 500mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emma Wightman

Northumbria university

Phone: +44 (0) 191 2437253

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place