Cognitive Function and MoodNCT03448094
The Effects of Resveratrol Supplementation on Cognition, Cerebral Blood Flow, Microbiota and Systemic Inflammation.
A study testing Resveratrol in people with Cognitive Function and Mood and Cerebral Blood Flow, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Previous research shows that a diet high in fat has harmful effects on gut health. This increases the chance of developing obesity-related diseases (such as type 2 diabetes) and disrupts cognition and mood. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function and Mood, Cerebral Blood Flow, Systemic Inflammation
- 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
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2018to 13 Jul 2019
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Interested in taking part in the study
- Healthy
- Aged 35-60 years (inclusive)
- Have a BMI of between 25-39.9
- Willing to consume your normal diet during the 12 week supplementation period
Who cannot join
- You should not take part if you:
- Are aged under 35 or over 60
- Have a Body Mass Index (BMI) lower than 25 or higher than 39.9.
- Have taken antibiotics (including pre- and pro-biotic supplements/drinks) during the previous 8 weeks
- Have irregular bowel movements (less than 1 per day)
- Have any pre-existing medical conditions/illness with some exceptions - please check with the researcher
Show all 29Show fewer
- Have type 1 or type 2 diabetes
- Are currently taking prescription medications with some exceptions- please check with the researcher
- Have a visual impairment that cannot be corrected by glasses or contact lenses, including colour blindness.
- English is not your first language or your English proficiency is not equivalent to the International English language test system (IELTS) band 6 or above
- Have any learning difficulties or dyslexia
- Currently suffer from frequent migraines that require medication (>1 per month)
- Have any food allergies, intolerances or sensitivities
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Smoke
- Have a history of alcohol or drug abuse
- Are pregnant, seeking to become pregnant or lactating
- Are unable to complete all of the study assessments
- Are currently participating in any other clinical or nutritional intervention study, or have done within the past 4 weeks
- Have any health condition that would prevent fulfilment of the study requirements
- Have habitually used supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
- Have an excessive caffeine intake (>500mg per day) - equivalent to 5/6 cups of coffee/8 cups of tea per day or equivalent from other sources
- Consume more than 5 portions of fruit or vegetables per day
- Any sleep disturbances or take sleep aid medication
- Have any known active infections
- You have or may think you are at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus?
- You have ever had breast cancer and/or a mastectomy
- You have haemophilia or any similar clotting disorder
- Do not have a bank account (required for payment)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Acute and Chronic Effects of Resveratrol Supplementation on Cognitive Function, Gastrointestinal Microbiota and Cerebral Blood Flow: a Double-blind, Placebo-controlled, Parallel-groups Study in Healthy, Overweight Humans.
Previous research shows that a diet high in fat has harmful effects on gut health. This increases the chance of developing obesity-related diseases (such as type 2 diabetes) and disrupts cognition and mood.
Research has suggested that gut health can be improved by taking certain supplements, including resveratrol (a polyphenol found primarily in red grape skins). Resveratrol has also been shown to improve brain blood flow and possibly brain function - however, there is limited research studying this.
This study will investigate the effects of 12 weeks daily consumption of resveratrol on cognitive function, cerebral blood flow, gut microbiota and systemic inflammation in overweight and obese healthy adults.
Read the detailed description
Each participant will be required to attend the laboratory on four occasions. The first of these will be an initial screening/training visit, this will take place in the afternoon and last 3 hours in total. During the initial visit participants will be asked to provide written informed consent. They will provide lifestyle and demographic data and screened regards to physical health (height, weight, blood pressure, waist to hip ratio). They will then be trained on the computerised cognitive and mood tasks. At the end of the appointment they will be provided with a food diary and a stool sample collection kit.
Study days 1 and 2 (12 weeks apart) :
Participants will arrive at the laboratory at 8.00am having fasted from 8pm the previous evening, avoided caffeinated products for 18 hours, alcohol and over the counter medication for 24 hours and oral antihistamines for 48 hours prior to the session commencing. They will also bring with them their completed food diary and stool sample.
Participants will provide a blood sample and then will be given a standardised breakfast of x2 slices of white toast with butter and a decaf tea or coffee. They will also provide a urine sample. Participants will then complete a computerised cognitive assessment (~1 hour in length), followed by measurements of blood pressure and heart rate. Participants in the sub-sample who will also provide brain (cerebral) blood flow data, will then have the quantitative near-infrared spectroscopy (qNIRS) headband fitted across the forehead and a 5 minute baseline measure will be recorded.
Following this the participants will consume their treatment for the day, followed by a short break and then will complete the second cognitive assessment. The qNIRS participants will again provide brain blood flow data and following that will be provided with a standardised lunch (cheese sandwich, ready salted crisps and a custard pot). Participants will complete their final cognitive assessment and will then provide a second blood sample.
At the end of the first study day participants will be provided with their treatment and treatment diary, they will be instructed to take one tablet twice a day (with breakfast and dinner). Both study days will be identical and will take place 84 days (+/- 5 days) apart.
Participants are also required to attend a short treatment exchange visit during Week 6 (5 minutes).
- Conditions
- Cognitive Function and Mood, Cerebral Blood Flow, Systemic Inflammation, Gut Microbiota, Overweight and Obesity
- Being tested
- Resveratrol, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Also called Veri-teTM Resveratrol
Participants will consume one of the treatment types daily for a period of three months.
PlaceboDietary supplement
Participants will consume one of the treatment types daily for a period of three months.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | 500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day). Receives: Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Matched placebo capsules (1 capsule consumed at two timepoints each day). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cognitive (memory) performance at 45 minutes, 240 minutes and 12 weeks post dose
Memory performance will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Memory will be assessed using 3 global measures (Working memory, speed of memory and episodic memory). The global measures are created by taking data from several tasks targeting that cognitive domain. Working memory: a combined accuracy score (% correct) from the tasks: numeric working memory (NWM), serial 3's subtractions (SS3), serial 7's subtractions (SS7) and rapid visual information processing (RVIP). Speed of memory: a combined speed score (msecs) from tasks NWM, delayed name to face recall, delayed picture recognition and delayed word recognition. Episodic memory: a combined accuracy score (% correct) from tasks immediate word recall, delayed word recall, delayed name to face recall, delayed picture recognition, delayed word recognition.
Measured: 45 minutes, 240 minutes, 12 weeks
Change from baseline cognitive (Attention) performance at 45 minutes, 240 minutes and 12 weeks post dose
Attention performance will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Attention will be assessed using 2 global measures (Accuracy of Attention and Speed of Attention). Accuracy of Attention: accuracy score (% correct) from choice reaction time task. Speed of attention: speed score (msecs) taken from choice reaction time task.
Measured: 45 minutes, 240 minutes, 12 weeks
Gut microbiota
Changes in gut microbiota communities, quantified using 16S ribosomal ribonucleic acid (rRNA) gene community analysis.
Measured: 12 weeks
Change from baseline systemic inflammatory cytokines
Inflammatory cytokines (including C-reactive protein and Interleukin-6) will be measured in plasma using ELISA analysis, in association with other endpoints including resveratrol metabolites.
Measured: 5 hours, 12 weeks
Change from baseline urinary and plasma metabolome
Changes in plasma and urinary metabolome will be profiled using a Thermo Q-Exactive liquid chromatography/mass spectrometry spectrometer and data analysed using Progenesis QI.
Measured: 12 weeks
Change from baseline total haemoglobin cerebral blood flow (CBF) measurement
CBF of the frontal cortex measured using quantitative near infrared spectroscopy (q-NIRS).
Measured: 115-190 minutes, 12 weeks
Change from baseline deoxygenated haemoglobin CBF measurement
CBF of the frontal cortex measured using qNIRS.
Measured: 115-190 minutes, 12 weeks
Change from baseline oxygen saturation CBF measurement
CBF of the frontal cortex measured using qNIRS.
Measured: 115-190 minutes, 12 weeks
Secondary outcomes (4)
Change from baseline Blood Pressure
Systolic and diastolic blood pressure will be taken after each cognitive assessment (measured in mm Hg).
Measured: 45 minutes, 240 minutes, 12 weeks
Change from baseline Heart Rate
Heart rate will be measured after each cognitive assessment (measured in BPM).
Measured: 45 minutes, 240 minutes, 12 weeks
Change from baseline subjective mood score
Subjective mood scores will be measured using the Profile of Mood scale. The questionnaire includes 65 items and participants rate their mood on a scale of 0-4 (not at all - extremely). These scores are collapsed into 6 mood outcomes (Tension, depression, anger, vigour, fatigue and confusion) and a total mood disturbance score.
Measured: 240 minutes, 12 weeks
Weight change and BMI
Change in weight and BMI between visits
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start6 Feb 2018
- Primary completion13 Jul 2019
- Study completion13 Jul 2019
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 Cognitive Function and MoodStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will recieve either Resveratrol or Placebo for a period of 3 months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Evolva SA
- Responsible party
- Principal investigator, EllenSmith, Northumbria University
- Investigators
- Emma Wightman, Dr, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448094
- Sponsor's protocol ID
- 52P6
- Status last verified
- Mar 2020
- First submitted
- 7 Feb 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wightman E, Lodge J, Kennedy D, Bowerbank S, Cheung W, Cuthbertson L, Nelson A, Smith D. The effects of 12-weeks resveratrol supplementation on cognition, gastrointestinal microbiota, and systemic inflammation, in an overweight and obese human population: a randomized, double-blind, placebo controlled, parallel groups trial. Front Nutr. 2026 Jul 1;13:1839709. doi: 10.3389/fnut.2026.1839709. eCollection 2026.
PubMed 42459802
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Effects of Resveratrol Supplementation on Cognitive Function, Gastrointestinal Microbiota and Cerebral Blood Flow: a Double-blind, Placebo-controlled, Parallel-groups Study in Healthy, Overweight Humans.
- ClinicalTrials.gov ID
- NCT03448094
- Acronym / sponsor ID
- 52P6
- Conditions
- Cognitive Function and Mood, Cerebral Blood Flow, Systemic Inflammation, Gut Microbiota, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Evolva SA
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 13 Jul 2019 (actual)
- Study completion
- 13 Jul 2019 (actual)
- First posted
- 27 Feb 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.
Previous research shows that a diet high in fat has harmful effects on gut health. This increases the chance of developing obesity-related diseases (such as type 2 diabetes) and disrupts cognition and mood.
Research has suggested that gut health can be improved by taking certain supplements, including resveratrol (a polyphenol found primarily in red grape skins). Resveratrol has also been shown to improve brain blood flow and possibly brain function - however, there is limited research studying this.
This study will investigate the effects of 12 weeks daily consumption of resveratrol on cognitive function, cerebral blood flow, gut microbiota and systemic inflammation in overweight and obese healthy adults.
Detailed description
Each participant will be required to attend the laboratory on four occasions. The first of these will be an initial screening/training visit, this will take place in the afternoon and last 3 hours in total. During the initial visit participants will be asked to provide written informed consent. They will provide lifestyle and demographic data and screened regards to physical health (height, weight, blood pressure, waist to hip ratio). They will then be trained on the computerised cognitive and mood tasks. At the end of the appointment they will be provided with a food diary and a stool sample collection kit.
Study days 1 and 2 (12 weeks apart) :
Participants will arrive at the laboratory at 8.00am having fasted from 8pm the previous evening, avoided caffeinated products for 18 hours, alcohol and over the counter medication for 24 hours and oral antihistamines for 48 hours prior to the session commencing. They will also bring with them their completed food diary and stool sample.
Participants will provide a blood sample and then will be given a standardised breakfast of x2 slices of white toast with butter and a decaf tea or coffee. They will also provide a urine sample. Participants will then complete a computerised cognitive assessment (~1 hour in length), followed by measurements of blood pressure and heart rate. Participants in the sub-sample who will also provide brain (cerebral) blood flow data, will then have the quantitative near-infrared spectroscopy (qNIRS) headband fitted across the forehead and a 5 minute baseline measure will be recorded.
Following this the participants will consume their treatment for the day, followed by a short break and then will complete the second cognitive assessment. The qNIRS participants will again provide brain blood flow data and following that will be provided with a standardised lunch (cheese sandwich, ready salted crisps and a custard pot). Participants will complete their final cognitive assessment and will then provide a second blood sample.
At the end of the first study day participants will be provided with their treatment and treatment diary, they will be instructed to take one tablet twice a day (with breakfast and dinner). Both study days will be identical and will take place 84 days (+/- 5 days) apart.
Participants are also required to attend a short treatment exchange visit during Week 6 (5 minutes).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will recieve either Resveratrol or Placebo for a period of 3 months.
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: Resveratrol500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatched placebo capsules (1 capsule consumed at two timepoints each day). |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Interested in taking part in the study
- Healthy
- Aged 35-60 years (inclusive)
- Have a BMI of between 25-39.9
- Willing to consume your normal diet during the 12 week supplementation period
Key exclusion criteria (29 listed)
- Are aged under 35 or over 60
- Have a Body Mass Index (BMI) lower than 25 or higher than 39.9.
- Have taken antibiotics (including pre- and pro-biotic supplements/drinks) during the previous 8 weeks
- Have irregular bowel movements (less than 1 per day)
- Have any pre-existing medical conditions/illness with some exceptions - please check with the researcher
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 |
|---|---|---|
| ResveratrolAlso: Veri-teTM ResveratrolParticipants will consume one of the treatment types daily for a period of three months. | Dietary supplement | Resveratrol |
| PlaceboParticipants will consume one of the treatment types daily for a period of three months. | Dietary supplement | Placebo |
Primary outcome
Change from baseline cognitive (memory) performance at 45 minutes, 240 minutes and 12 weeks post dose
Time frame: 45 minutes, 240 minutes, 12 weeks
Memory performance will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Memory will be assessed using 3 global measures (Working memory, speed of memory and episodic memory). The global measures are created by taking data from several tasks targeting that cognitive domain. Working memory: a combined accuracy score (% correct) from the tasks: numeric working memory (NWM), serial 3's subtractions (SS3), serial 7's subtractions (SS7) and rapid visual information processing (RVIP). Speed of memory: a combined speed score (msecs) from tasks NWM, delayed name to face recall, delayed picture recognition and delayed word recognition. Episodic memory: a combined accuracy score (% correct) from tasks immediate word recall, delayed word recall, delayed name to face recall, delayed picture recognition, delayed word recognition.
Change from baseline cognitive (Attention) performance at 45 minutes, 240 minutes and 12 weeks post dose
Time frame: 45 minutes, 240 minutes, 12 weeks
Attention performance will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Attention will be assessed using 2 global measures (Accuracy of Attention and Speed of Attention). Accuracy of Attention: accuracy score (% correct) from choice reaction time task. Speed of attention: speed score (msecs) taken from choice reaction time task.
Gut microbiota
Time frame: 12 weeks
Changes in gut microbiota communities, quantified using 16S ribosomal ribonucleic acid (rRNA) gene community analysis.
Change from baseline systemic inflammatory cytokines
Time frame: 5 hours, 12 weeks
Inflammatory cytokines (including C-reactive protein and Interleukin-6) will be measured in plasma using ELISA analysis, in association with other endpoints including resveratrol metabolites.
Change from baseline urinary and plasma metabolome
Time frame: 12 weeks
Changes in plasma and urinary metabolome will be profiled using a Thermo Q-Exactive liquid chromatography/mass spectrometry spectrometer and data analysed using Progenesis QI.
Change from baseline total haemoglobin cerebral blood flow (CBF) measurement
Time frame: 115-190 minutes, 12 weeks
CBF of the frontal cortex measured using quantitative near infrared spectroscopy (q-NIRS).
Change from baseline deoxygenated haemoglobin CBF measurement
Time frame: 115-190 minutes, 12 weeks
CBF of the frontal cortex measured using qNIRS.
Change from baseline oxygen saturation CBF measurement
Time frame: 115-190 minutes, 12 weeks
CBF of the frontal cortex measured using qNIRS.
4 secondary outcomes
Change from baseline Blood Pressure
Time frame: 45 minutes, 240 minutes, 12 weeks
Change from baseline Heart Rate
Time frame: 45 minutes, 240 minutes, 12 weeks
Change from baseline subjective mood score
Time frame: 240 minutes, 12 weeks
Weight change and BMI
Time frame: 12 weeks
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 17 Mar 2020.
- Derived from this study: PubMed 42459802Wightman E, Lodge J, Kennedy D, Bowerbank S, Cheung W, Cuthbertson L, Nelson A, Smith D. The effects of 12-weeks resveratrol supplementation on cognition, gastrointestinal microbiota, and systemic inflammation, in an overweight and obese human population: a randomized, double-blind, placebo controlled, parallel groups trial. Front Nutr. 2026 Jul 1;13:1839709. doi: 10.3389/fnut.2026.1839709. eCollection 2026.
- Individual participant dataSharing planned: No
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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 Wightman, Dr 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 Resveratrol in people with Cognitive Function and Mood and Cerebral Blood Flow, 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 5 inclusion and 29 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 17 Mar 2020. 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?
Change from baseline cognitive (memory) performance at 45 minutes, 240 minutes and 12 weeks post dose (time frame: 45 minutes, 240 minutes, 12 weeks). The study lists 8 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 NCT03448094, 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 17 Mar 2020.