HealthyPhase 1NCT01640197
Chronic Resveratrol Supplementation in Healthy Humans
A Phase 1 study testing Resveratrol in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. It is hypothesised that the effects will be different to those seen in acute supplementation. 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?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Jun 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy
- Between 18-35
- At least enrolled on undergraduate degree programme
- Native English speaker
Who cannot join
- Smoking
- Taking other medication/ supplements
- Pregnant/ breast feeding
- High caffeine consumers
- Migraine sufferers
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: The Effects of Chronic Trans- Resveratrol Supplementation on Aspects of Cognitive Performance, Mood, Sleep, Health and Cerebral Blood Flow in Healthy, Young Humans.
The effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. It is hypothesised that the effects will be different to those seen in acute supplementation. This study will look specifically at cognitive performance, cerebral blood flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It is hypothesized that these measures will be affected differently by acute and chronic supplementation.
- Conditions
- Healthy
- Being tested
- Resveratrol, Placebo
- Keywords
- Cognitive performance, Cerebral blood flow, Subjective sleep, Subjective mood, Subjective health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.
PlaceboOther
Methyl Cellulose. 1 capsule taken once daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Methyl Cellulose administered in identical capsules as the active. Receives: Other: Placebo |
| 500mg resveratrol | Active comparator | Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily. Receives: Dietary Supplement: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Modulation of Cerebral Blood Flow
Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28.
Measured: 40- 80 minutes post- dose on day 28 of supplementation
Secondary outcomes (6)
Number of Participants With Modulated Mood
Subjective mood was assessed with the Profile of mood states (POMS) questionnaire every 7 days during the 28- day period. Participants were deemed to have significant modulation of mood if their scores on week 1, week 2, week 3 and/or week 4 differed significantly from scores on the baseline questionnaire completed on day 1.
Measured: 28 days
Number of Participants With Modulated Cognitive Performance
Cognitive performance was assessed by a range of cognitively demanding tasks on day 28 of the supplementation period. Participants were deemed to have significant modulation of cognitive performance if their scores on these tasks were significantly different from scores taken on day 1.
Measured: 28 days
Number of Participants With Significant Modulation of Sleep
Subjective perception of sleep quality was assessed with the PSQI. Participants were deemed to have significant modulation of sleep if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from those on day 1 (baseline).
Measured: Day 28
Number of Participants With Significant Modulation of Health
Subjective perceptions of health were assessed with the General Health Questionnaire. Participants were deemed to have significant modulation of health if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from day 1 (baseline) completion.
Measured: Day 28
Number of Participants With Significant Modulation of Blood Pressure
Participants were deemed to have significant modulation of blood pressure if their readings on day 28 differed significantly from that taken on day 1 (baseline).
Measured: 28 days
Number of Participants With Significant Modulation of CBF in MCA
CBF was assessed in the middle cerebral artery (MCA) with Trans-cranial doppler via a trans- temporal acoustic window. Participants were deemed to have significant modulation of CBF in the MCA if readings differed significantly from those obtained on day 1 (baseline).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Biotivia Longevity Bioceuticals
- Responsible party
- Principal investigator, David Kennedy, Northumbria University
- Investigators
- David O Kennedy, Professor, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640197
- Sponsor's protocol ID
- 22P4
- Status last verified
- Aug 2012
- First submitted
- 10 Jul 2012
- Last updated
- 19 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chronic Trans- Resveratrol Supplementation on Aspects of Cognitive Performance, Mood, Sleep, Health and Cerebral Blood Flow in Healthy, Young Humans.
- ClinicalTrials.gov ID
- NCT01640197
- Acronym / sponsor ID
- 22P4
- Conditions
- Healthy
- Keywords
- Cognitive performance, Cerebral blood flow, Subjective sleep, Subjective mood, Subjective health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Biotivia Longevity Bioceuticals
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. It is hypothesised that the effects will be different to those seen in acute supplementation. This study will look specifically at cognitive performance, cerebral blood flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It is hypothesized that these measures will be affected differently by acute and chronic supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMethyl Cellulose administered in identical capsules as the active. |
| 500mg resveratrol | Active comparator | Dietary Supplement: ResveratrolTransmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Between 18-35
- At least enrolled on undergraduate degree programme
- Native English speaker
Key exclusion criteria (5 listed)
- Smoking
- Taking other medication/ supplements
- Pregnant/ breast feeding
- High caffeine consumers
- Migraine sufferers
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 |
|---|---|---|
| ResveratrolTransmax (Biotivia). 500mg (1 capsule) per day for 28 days. | Dietary supplement | 500mg resveratrol |
| PlaceboMethyl Cellulose. 1 capsule taken once daily for 28 days. | Other | Placebo |
Primary outcome
Chronic Modulation of Cerebral Blood Flow
Time frame: 40- 80 minutes post- dose on day 28 of supplementation
Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28.
6 secondary outcomes
Number of Participants With Modulated Mood
Time frame: 28 days
Number of Participants With Modulated Cognitive Performance
Time frame: 28 days
Number of Participants With Significant Modulation of Sleep
Time frame: Day 28
Number of Participants With Significant Modulation of Health
Time frame: Day 28
Number of Participants With Significant Modulation of Blood Pressure
Time frame: 28 days
Number of Participants With Significant Modulation of CBF in MCA
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David O Kennedy, Professor 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 Phase 1 study testing 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 4 inclusion and 5 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 19 Oct 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Chronic Modulation of Cerebral Blood Flow (time frame: 40- 80 minutes post- dose on day 28 of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2012.