HealthyNCT01331382
Cerebral Blood Flow Effects of Resveratrol and Piperine in Humans
A study testing Trans- resveratrol in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Trans- resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35 years old
- Healthy
- Non-smoker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Trans- resveratrol, Placebo (silica)
- Keywords
- Resveratrol, Piperine, Cerebral blood flow, Near- infrared spectroscopy, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans- resveratrolDietary supplement
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.
Placebo (silica)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 250mg trans- resveratrol | Experimental | Not described Receives: Dietary Supplement: Trans- resveratrol; Other: Placebo (silica) |
| 250mg trans-resveratrol with 20mg piperine | Experimental | Not described Receives: Dietary Supplement: Trans- resveratrol; Other: Placebo (silica) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Trans- resveratrol; Other: Placebo (silica) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of levels of total haemoglobin
Measured: 80 minutes following treatment administration
Modulation of levels of deoxygenated haemoglobin
Measured: 80 minutes following treatment administration
Modulation of levels of oxygenated haemoglobin
Measured: 80 minutes following treatment administration
Secondary outcomes (1)
Number of participants displaying significant modulation of cognitive performance
Cognitive performance was assessed at baseline and then again 40 minutes post-treatment to assess if any changes had taken place.
Measured: 40-80 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Investigators
- Emma L Wightman, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331382
- Sponsor's protocol ID
- 22AB2
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wightman EL, Reay JL, Haskell CF, Williamson G, Dew TP, Kennedy DO. Effects of resveratrol alone or in combination with piperine on cerebral blood flow parameters and cognitive performance in human subjects: a randomised, double-blind, placebo-controlled, cross-over investigation. Br J Nutr. 2014 Jul 28;112(2):203-13. doi: 10.1017/S0007114514000737. Epub 2014 May 7.
PubMed 24804871
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resveratrol Alone or in Combination With Piperine on Cerebral Blood Flow Parameters and Cognitive Performance in Humans
- ClinicalTrials.gov ID
- NCT01331382
- Acronym / sponsor ID
- 22AB2
- Conditions
- Healthy
- Keywords
- Resveratrol, Piperine, Cerebral blood flow, Near- infrared spectroscopy, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 250mg trans- resveratrol | Experimental | Dietary Supplement: Trans- resveratrol, Other: Placebo (silica) |
| 250mg trans-resveratrol with 20mg piperine | Experimental | Dietary Supplement: Trans- resveratrol, Other: Placebo (silica) |
| Placebo | Placebo comparator | Dietary Supplement: Trans- resveratrol, Other: Placebo (silica) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18-35 years old
- Healthy
- Non-smoker
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans- resveratrolAll 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. | Dietary supplement | 250mg trans- resveratrol, 250mg trans-resveratrol with 20mg piperine, Placebo |
| Placebo (silica)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. | Other | 250mg trans- resveratrol, 250mg trans-resveratrol with 20mg piperine, Placebo |
Primary outcome
Modulation of levels of total haemoglobin
Time frame: 80 minutes following treatment administration
Modulation of levels of deoxygenated haemoglobin
Time frame: 80 minutes following treatment administration
Modulation of levels of oxygenated haemoglobin
Time frame: 80 minutes following treatment administration
1 secondary outcome
Number of participants displaying significant modulation of cognitive performance
Time frame: 40-80 minutes post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
- Derived from this study: PubMed 24804871Wightman EL, Reay JL, Haskell CF, Williamson G, Dew TP, Kennedy DO. Effects of resveratrol alone or in combination with piperine on cerebral blood flow parameters and cognitive performance in human subjects: a randomised, double-blind, placebo-controlled, cross-over investigation. Br J Nutr. 2014 Jul 28;112(2):203-13. doi: 10.1017/S0007114514000737. Epub 2014 May 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma L Wightman principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans- resveratrol in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modulation of levels of total haemoglobin (time frame: 80 minutes following treatment administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2011.