- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331382
Cerebral Blood Flow Effects of Resveratrol and Piperine in Humans
April 7, 2011 updated by: Northumbria University
Effects of Resveratrol Alone or in Combination With Piperine on Cerebral Blood Flow Parameters and Cognitive Performance in Humans
Resveratrol is associated with a plethora of physiological effects in humans, including modulation of cerebral blood flow, despite apparently poor bioavailability.
This study investigated whether the physiological effects of resveratrol could be affected when co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability of resveratrol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
-
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Brain performance and nutrition research centre, Northumbria university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 33 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 18-35 years old
- Healthy
- Non-smoker
Exclusion Criteria:
- Not proficient in English
- Taking medication or herbal supplements
- Pregnant or breast feeding
- Heavy caffeine consumer
- History of head trauma, migraines, learning difficulties, ADHD, gastrointestinal problems.
- Food allergies of intolerances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square.
Treatment was in the form of powder and administered in capsule form, in a double blind manner.
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square.
Treatment was in the form of powder and administered in capsule form, in a double blind manner.
|
Experimental: 250mg trans- resveratrol
|
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square.
Treatment was in the form of powder and administered in capsule form, in a double blind manner.
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square.
Treatment was in the form of powder and administered in capsule form, in a double blind manner.
|
Experimental: 250mg trans-resveratrol with 20mg piperine
|
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square.
Treatment was in the form of powder and administered in capsule form, in a double blind manner.
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square.
Treatment was in the form of powder and administered in capsule form, in a double blind manner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modulation of levels of total haemoglobin
Time Frame: 80 minutes following treatment administration
|
80 minutes following treatment administration
|
Modulation of levels of deoxygenated haemoglobin
Time Frame: 80 minutes following treatment administration
|
80 minutes following treatment administration
|
Modulation of levels of oxygenated haemoglobin
Time Frame: 80 minutes following treatment administration
|
80 minutes following treatment administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants displaying significant modulation of cognitive performance
Time Frame: 40-80 minutes post dose
|
Cognitive performance was assessed at baseline and then again 40 minutes post-treatment to assess if any changes had taken place.
|
40-80 minutes post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emma L Wightman, Northumbria University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
April 6, 2011
First Submitted That Met QC Criteria
April 7, 2011
First Posted (Estimate)
April 8, 2011
Study Record Updates
Last Update Posted (Estimate)
April 8, 2011
Last Update Submitted That Met QC Criteria
April 7, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22AB2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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