Cognitive ChangeNCT03546075
The Impact of Acute Trans-resveratrol Administration on Whole Body Metabolism During Cognitive Demand.
A study testing Resveratrol in people with Cognitive Change, run by Northumbria University.
Trial summary
Background: Increased cerebral vaso-dilation during cognitive demand is hypothesised to improve cognitive performance due to an improved micronutrient status. Despite previous research demonstrating that oral resveratrol can modulate cerebral haemodynamics, this has not translated into expected improvements to… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2015to 18 Dec 2015
- 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
- Participants who were able to give informed consent.
- Those who didn't meet any of the exclusion criteria.
- Those who took hormonal contraception (e.g. the pill, coil, implant, etc.) were still allowed to participate in the current study.
Who cannot join
- Participants who smoke.
- Participants below the age of 18 years or above 35 years at the time of giving consent to in role in the current study.
- Participants with Body Mass Index outside the range of 18-35 kg/m2.
- Participants with blood pressure greater than 140/90 HH/mg.
- Participants with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety).
- Participants with a current diagnosis of depression and / or anxiety.
Show all 18Show fewer
- Participants with learning difficulties: dyslexia, dyscalculia or colour blindness.
- Participants with a visual impairment that cannot be corrected with glasses or contact lenses.
- Participants with frequent migraines that require medication (more than or equal to 1 per month).
- Participants with disorders of the blood.
- Participants with a heart disorder.
- Participants with diabetes.
- Participants with a respiratory disorder that requires regular medication (Note: asthma sufferers who only take their medication occasionally/as required were eligible for this study).
- Participants currently taking any prescription medications.
- Participants who have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total).
- Participants with any food intolerances/sensitivities.
- Participants with a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g., iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation.
- Female participants who are currently pregnant, lactating or seeking to become pregnant.
About this study
Official title: The Impact of Acute Trans-resveratrol Administration on Whole Body Metabolism During Cognitive Task Performance: a Double Blind, Randomised, Placebo-controlled Investigation.
Background: Increased cerebral vaso-dilation during cognitive demand is hypothesised to improve cognitive performance due to an improved micronutrient status. Despite previous research demonstrating that oral resveratrol can modulate cerebral haemodynamics, this has not translated into expected improvements to cognitive performance in young, healthy populations. As the brain is the most metabolic organ in the body, even subtle changes to fuel utilization and overall energy expenditure are detectable during cognitive demand. The measurement of both overall energy expenditure and fuel utilization may provide further insight to the effects of resveratrol and whether oral supplementation of this polyphenol can provide clear, cognitive benefits in a young, healthy sample.
Objectives: The current study investigated the metabolic consequences of resveratrol on whole body metabolism and fuel oxidisation during cognitive performance.
Methods: This repeated measures, double blind, placebo controlled, balanced design required participants (N=24 for metabolic activity \& N=26 for cognitive outcomes) to complete a serial subtraction demand battery at baseline, 45 minutes, 2 and 3 hours following 500 mg, 250 mg trans-resveratrol or inert placebo, on three separate occasions whilst connected to an on-line gas analysis system.
- Conditions
- Cognitive Change
- Being tested
- Resveratrol, Placebo
- Keywords
- Cognition, Resveratrol, Whole body metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 500 mg Resveratrol | Experimental | Not described Receives: Dietary Supplement: Resveratrol |
| 250 mg Resveratrol | Experimental | Not described Receives: Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Participants completed three Serial subtraction tasks (Serial 3, 7 \& 17). Outcomes measured from all three of these tasks were the number correct entries and number of errors. The addition of the two outcomes can also provide a 'total' number of responses entered.
Measured: 1 Hour
Whole body metabolism
Whole body energy expenditure was measured via indirect calorimetry and was reported in calories burned per minute (Kcal / min).
Measured: 1 Hour
Fuel Oxidisation
Fuel oxidation was measured via indirect calorimetry and examined the rate of carbohydrate and fat oxidisation (both in grams per minute (g / min)).
Measured: 1 Hour
Secondary outcomes (1)
Pulmonary gases
An on-line gas analysis system was used to measure oxygen intake and carbon dioxide excretion (both in litres per minute (L / min)) from the participant's expired pulmonary air.
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start7 May 2015
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Eschle, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546075
- Sponsor's protocol ID
- 42BB1
- Status last verified
- Jun 2018
- First submitted
- 9 Apr 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acute Trans-resveratrol Administration on Whole Body Metabolism During Cognitive Task Performance: a Double Blind, Randomised, Placebo-controlled Investigation.
- ClinicalTrials.gov ID
- NCT03546075
- Acronym / sponsor ID
- 42BB1
- Conditions
- Cognitive Change
- Keywords
- Cognition, Resveratrol, Whole body metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 7 May 2015 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 6 Jun 2018 (actual)
- 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.
Background: Increased cerebral vaso-dilation during cognitive demand is hypothesised to improve cognitive performance due to an improved micronutrient status. Despite previous research demonstrating that oral resveratrol can modulate cerebral haemodynamics, this has not translated into expected improvements to cognitive performance in young, healthy populations. As the brain is the most metabolic organ in the body, even subtle changes to fuel utilization and overall energy expenditure are detectable during cognitive demand. The measurement of both overall energy expenditure and fuel utilization may provide further insight to the effects of resveratrol and whether oral supplementation of this polyphenol can provide clear, cognitive benefits in a young, healthy sample.
Objectives: The current study investigated the metabolic consequences of resveratrol on whole body metabolism and fuel oxidisation during cognitive performance.
Methods: This repeated measures, double blind, placebo controlled, balanced design required participants (N=24 for metabolic activity \& N=26 for cognitive outcomes) to complete a serial subtraction demand battery at baseline, 45 minutes, 2 and 3 hours following 500 mg, 250 mg trans-resveratrol or inert placebo, on three separate occasions whilst connected to an on-line gas analysis system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 500 mg Resveratrol | Experimental | Dietary Supplement: Resveratrol |
| 250 mg Resveratrol | Experimental | Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who were able to give informed consent.
- Those who didn't meet any of the exclusion criteria.
- Those who took hormonal contraception (e.g. the pill, coil, implant, etc.) were still allowed to participate in the current study.
Key exclusion criteria (18 listed)
- Participants who smoke.
- Participants below the age of 18 years or above 35 years at the time of giving consent to in role in the current study.
- Participants with Body Mass Index outside the range of 18-35 kg/m2.
- Participants with blood pressure greater than 140/90 HH/mg.
- Participants with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety).
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 |
|---|---|---|
| Resveratrol | Dietary supplement | 250 mg Resveratrol, 500 mg Resveratrol |
| Placebo | Other | Placebo |
Primary outcome
Cognitive performance
Time frame: 1 Hour
Participants completed three Serial subtraction tasks (Serial 3, 7 \& 17). Outcomes measured from all three of these tasks were the number correct entries and number of errors. The addition of the two outcomes can also provide a 'total' number of responses entered.
Whole body metabolism
Time frame: 1 Hour
Whole body energy expenditure was measured via indirect calorimetry and was reported in calories burned per minute (Kcal / min).
Fuel Oxidisation
Time frame: 1 Hour
Fuel oxidation was measured via indirect calorimetry and examined the rate of carbohydrate and fat oxidisation (both in grams per minute (g / min)).
1 secondary outcome
Pulmonary gases
Time frame: 1 Hour
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 6 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol in people with Cognitive Change, run by Northumbria University.
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 18 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Cognitive performance (time frame: 1 Hour). 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?
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 6 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.