The Cognitive and Cerebral Blood Flow Effects of Resveratrol

• Sponsor: Northumbria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01010009
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by interacting with nitric oxide (NO). Research also shows that acute administration of metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance in young, healthy humans. The aim of this investigation was to determine if the consumption of resveratrol could modulate cerebral blood flow and if this in turn could influence cognitive performance by increasing access to blood borne metabolic fuel. Results showed that compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total haemoglobin were significantly higher in the frontal cortex of young, healthy participants during cognitive task completion. Cognitive performance was not effected.

Condition or Disease	Intervention/Treatment	Phase
Cognitive and Cerebral Blood Flow Effects of Resveratrol	Dietary Supplement: Trans- resveratrol; Other: Placebo (silica)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Resveratrol on Cerebral Blood Flow Parameters and Cognitive Performance in Humans: a Double-blind, Placebo-controlled, Crossover Investigation
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resveratrol 250mg	Dietary Supplement: Trans- resveratrol; All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.; Other Names: Transmax from Biotivia. ; Other: Placebo (silica); All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.; Other Names: Pharmaceutical grade silica
Experimental: Resveratrol 500mg	Dietary Supplement: Trans- resveratrol; All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.; Other Names: Transmax from Biotivia. ; Other: Placebo (silica); All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.; Other Names: Pharmaceutical grade silica
Placebo Comparator: Placebo	Dietary Supplement: Trans- resveratrol; All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.; Other Names: Transmax from Biotivia. ; Other: Placebo (silica); All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.; Other Names: Pharmaceutical grade silica

Outcome Measures

Primary Outcome Measures

1. Modulation of Levels of Total Haemoglobin [0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)]

   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).

2. Modulation of Deoxygenated Levels of Haemoglobin [0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)]

   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).

Secondary Outcome Measures

1. Number of Participants With Significant Modulation of Cognitive Performance [46-81 mins post dose]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male/female,

• Healthy

• Age 18-35 years old

• Non smoker

• Proficient in English

• Not taking any herbal or prescription medications

• Not pregnant

• Does not drink more than 6 cups of coffee per day

Exclusion Criteria:

• Suffered a head injury, neurological disorder or neuro-developmental disorder

• Food allergies/intolerances

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northumbria University	Newcastle upon Tyne		United Kingdom	NE1 8ST

Sponsors and Collaborators

• Northumbria University

Investigators

• Study Director: Crystal Haskell, Northumbria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01010009
• Other Study ID Numbers: 22P2
• First Posted: Nov 9, 2009
• Last Update Posted: May 23, 2012
• Last Verified: May 1, 2012

• Keywords provided by , ,: resveratrol; cerebral blood flow; NIRS; cognitive performance
• Additional relevant MeSH terms: Resveratrol

Study Results

Participant Flow

Arm/Group Title	Resveratrol 250mg Then Resveratrol 500mg Then Placebo	Resveratrol 500mg Then Placebo Then Resveratrol 250mg	Placebo Then Resveratrol 250mg Then Resveratrol 500mg
Arm/Group Description
Period Title: Overall Study
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Resveratrol 250mg Then Resveratrol 500mg Then Placebo	Resveratrol 500mg Then Placebo Then Resveratrol 250mg	Placebo Then Resveratrol 250mg Then Resveratrol 500mg	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	8	8	8	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	8 100%	8 100%	8 100%	24 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.2 (2.2)	21.3 (1.8)	20 (2)	20 (2)
Sex: Female, Male (Count of Participants)
Female	6 75%	7 87.5%	7 87.5%	20 83.3%
Male	2 25%	1 12.5%	1 12.5%	4 16.7%
Region of Enrollment (participants) [Number]
United Kingdom	8 100%	8 100%	8 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Modulation of Levels of Total Haemoglobin
Description	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).
Time Frame	0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Resveratrol 250mg	Resveratrol 500mg	Placebo
Arm/Group Description
Measure Participants	22	22	22
Mean (Standard Error) [µmol/L]	1.9 (0.9)	2.4 (0.8)	1.2 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol 250mg, Placebo
	Comments	Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Resveratrol 500mg, Placebo
	Comments	Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Number of Participants With Significant Modulation of Cognitive Performance
Description	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.
Time Frame	46-81 mins post dose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Resveratrol 250mg	Resveratrol 500mg	Placebo
Arm/Group Description
Measure Participants	22	22	22
Number [Participants]	0 (0) 0%	0 (0) 0%	0 (0) 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol 250mg, Placebo
	Comments	Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Resveratrol 500mg, Placebo
	Comments	Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Modulation of Deoxygenated Levels of Haemoglobin
Description	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).
Time Frame	0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Resveratrol 250mg	Resveratrol 500mg	Placebo
Arm/Group Description
Measure Participants	22	22	22
Mean (Standard Error) [µmol/L]	0.4 (0.2)	0.2 (0.11)	-0.2 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol 250mg, Placebo
	Comments	An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Resveratrol 500mg, Placebo
	Comments	An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Arm/Group Title	Resveratrol 250mg		Resveratrol 500mg		Placebo
Arm/Group Description
All Cause Mortality
	Resveratrol 250mg		Resveratrol 500mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Resveratrol 250mg		Resveratrol 500mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Resveratrol 250mg		Resveratrol 500mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.