Cognitive ChangeNCT04314739
The Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults
A study testing Resveratrol in people with Cognitive Change and Mood, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Previous research has suggested that high levels of systemic inflammation can contribute to cognitive deficits and additional health problems; consumption of polyphenols have been shown to have an anti-inflammatory effect. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Mood, 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
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2019to 19 Dec 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must self-assess themselves as being in good health.
- Aged 18 to 55 at the time of giving consent
Who cannot join
- Have a Body Mass Index (BMI) outside the range of 18.5-42kg/m2
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 Inflammation and Cognitive Performance in Healthy Adults
Previous research has suggested that high levels of systemic inflammation can contribute to cognitive deficits and additional health problems; consumption of polyphenols have been shown to have an anti-inflammatory effect. Resveratrol, a polyphenol found primarily in red grape skins, has previously been shown to improve brain blood flow and possibly brain function and may potentially reduce systemic inflammation, however there is limited research into this.
This study will investigate the effects of 4 weeks daily consumption of resveratrol on inflammation and cognitive function in healthy adults.
Read the detailed description
Each participant will be required to attend the laboratory on three occasions. The first of these will be an initial screening/training visit, this will take place in the afternoon and last 2 1/2 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 complete a food frequency questionnaire and be trained on the computerised cognitive and mood tasks. Participants will also be trained on completing the cognitive assessment battery on their mobile phone, they will complete a further 5 assessments on their phone, once the day before their first visit and every 7 days during the supplementation period.
Study days 1 and 2 (4 weeks apart) :
Participants will arrive at the laboratory at an agreed time in the morning (7am, 8.30am or 10am) having fasted for 12 hours, 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.
Participants will provide a blood sample, they will then complete a short computerised cognitive assessment (~20 minutes in length), followed by measurements of blood pressure and heart rate. Following this the participants will consume their treatment for the day, followed by a 40 minute absorption period and then will complete the second cognitive assessment. Participants will then provide a second blood sample. At the end of the first study session participants will be provided with their treatment and treatment diary, they will be instructed to take one tablet twice a day (30 minutes after breakfast and dinner). Both study visits will be identical and will take place 29 days (+/- 2 days) apart.
- Conditions
- Cognitive Change, Mood, Systemic Inflammation
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, Polyphenol, Cognition, Mood, Inflammation
- Medical subject headings
- Inflammation
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 four weeks.
PlaceboDietary supplement
Participants will consume one of the treatment types daily for a period of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Active comparator | 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 concentration of biomarkers of systemic inflammation
Assessment of change from baseline: C reactive protein, tumor necrosis factor alpha and interleukin 6.
Measured: 1 hour post dose; 4 weeks
Secondary outcomes (11)
Acute changes in cognitive task performance
This will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Changes in episodic memory, working memory, spatial memory, executive function and attention as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains.
Measured: 40 minutes post dose
Interim changes in cognitive task performance
This will be assessed using a computerised cognitive battery, this will be administered using 'Cognimapp'mobile phone program, participants will complete this battery away from home using their own mobile phone. Changes in attention, executive function, working memory and episodic memory as compared to performance on Day -1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains.
Measured: Day 7; Day 14; Day 21; Day 28
Chronic changes in cognitive task performance
This will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Changes in episodic memory, working memory, spatial memory, executive function and attention as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains.
Measured: 4 weeks
Acute changes in mood
Assessed using Visual Analogue Mood Scales at each assessment during each cognitive assessment. Participants will complete 27 separate visual analogue mood scales that load onto 3 mood outcomes: Alertness, Stress and Tranquillity (the individual scale results are averaged to create this score). A score between 0 and 100 can be obtained, where a higher value indicates that the participant felt more Alert, Stressed or Tranquil.
Measured: 40 mins post dose
Interim changes in mood
Assessed using Visual Analogue Mood Scales at each assessment during the interim supplementation period. Participants will complete 27 separate visual analogue mood scales that load onto 3 mood outcomes: Alertness, Stress and Tranquillity (the individual scale results are averaged to create this score). A score between 0 and 100 can be obtained, where a higher value indicates that the participant felt more Alert, Stressed or Tranquil.
Measured: Day 7; Day 14; Day 21; Day 28
Chronic changes in mood
Assessed using the Profile of Mood States questionnaire, completed at the start of each testing visit. 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: 4 weeks
Acute changes in concentration of plasma and serum biomarkers
Biomarkers of insulin, glucose, cholesterol and resveratrol metabolites will be measured in plasma and serum using liquid chromatography-mass spectrometry and ELISA analysis in association with other endpoints.
Measured: 1 hour post dose
Chronic changes in concentration of plasma and serum biomarkers
Biomarkers of insulin, glucose, cholesterol and resveratrol metabolites will be measured in plasma and serum using liquid chromatography-mass spectrometry and ELISA analysis in association with other endpoints.
Measured: 4 weeks
Acute and chronic changes in blood pressure
Systolic and diastolic blood pressure will be taken after each cognitive assessment (measured in mm Hg).
Measured: 1 hour post dose, 4 weeks
Acute and chronic changes in heart rate
Heart rate will be measured after each cognitive assessment (measured in BPM).
Measured: 1 hour post dose, 4 weeks
Changes in weight and Body Mass Index (BMI)
Participants weight will be recorded at testing visits and BMI will be calculated.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start19 Mar 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Evolva SA
- Responsible party
- Sponsor
- Investigators
- Emma L Wightman, Dr, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314739
- Sponsor's protocol ID
- 52P7
- Status last verified
- Mar 2019
- First submitted
- 1 Apr 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 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 Inflammation and Cognitive Performance in Healthy Adults
- ClinicalTrials.gov ID
- NCT04314739
- Acronym / sponsor ID
- 52P7
- Conditions
- Cognitive Change, Mood, Systemic Inflammation
- Keywords
- Resveratrol, Polyphenol, Cognition, Mood, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Evolva SA
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 19 Mar 2020 (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 has suggested that high levels of systemic inflammation can contribute to cognitive deficits and additional health problems; consumption of polyphenols have been shown to have an anti-inflammatory effect. Resveratrol, a polyphenol found primarily in red grape skins, has previously been shown to improve brain blood flow and possibly brain function and may potentially reduce systemic inflammation, however there is limited research into this.
This study will investigate the effects of 4 weeks daily consumption of resveratrol on inflammation and cognitive function in healthy adults.
Detailed description
Each participant will be required to attend the laboratory on three occasions. The first of these will be an initial screening/training visit, this will take place in the afternoon and last 2 1/2 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 complete a food frequency questionnaire and be trained on the computerised cognitive and mood tasks. Participants will also be trained on completing the cognitive assessment battery on their mobile phone, they will complete a further 5 assessments on their phone, once the day before their first visit and every 7 days during the supplementation period.
Study days 1 and 2 (4 weeks apart) :
Participants will arrive at the laboratory at an agreed time in the morning (7am, 8.30am or 10am) having fasted for 12 hours, 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.
Participants will provide a blood sample, they will then complete a short computerised cognitive assessment (~20 minutes in length), followed by measurements of blood pressure and heart rate. Following this the participants will consume their treatment for the day, followed by a 40 minute absorption period and then will complete the second cognitive assessment. Participants will then provide a second blood sample. At the end of the first study session participants will be provided with their treatment and treatment diary, they will be instructed to take one tablet twice a day (30 minutes after breakfast and dinner). Both study visits will be identical and will take place 29 days (+/- 2 days) apart.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Active comparator | 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
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must self-assess themselves as being in good health.
- Aged 18 to 55 at the time of giving consent
Key exclusion criteria (1 listed)
- Have a Body Mass Index (BMI) outside the range of 18.5-42kg/m2
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 four weeks. | Dietary supplement | Resveratrol |
| PlaceboParticipants will consume one of the treatment types daily for a period of four weeks. | Dietary supplement | Placebo |
Primary outcome
Change from baseline concentration of biomarkers of systemic inflammation
Time frame: 1 hour post dose; 4 weeks
Assessment of change from baseline: C reactive protein, tumor necrosis factor alpha and interleukin 6.
11 secondary outcomes
Acute changes in cognitive task performance
Time frame: 40 minutes post dose
Interim changes in cognitive task performance
Time frame: Day 7; Day 14; Day 21; Day 28
Chronic changes in cognitive task performance
Time frame: 4 weeks
Acute changes in mood
Time frame: 40 mins post dose
Interim changes in mood
Time frame: Day 7; Day 14; Day 21; Day 28
Chronic changes in mood
Time frame: 4 weeks
Acute changes in concentration of plasma and serum biomarkers
Time frame: 1 hour post dose
Chronic changes in concentration of plasma and serum biomarkers
Time frame: 4 weeks
Acute and chronic changes in blood pressure
Time frame: 1 hour post dose, 4 weeks
Acute and chronic changes in heart rate
Time frame: 1 hour post dose, 4 weeks
Changes in weight and Body Mass Index (BMI)
Time frame: 4 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 19 Mar 2020.
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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, 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 Change and Mood, 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 2 inclusion and 1 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 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 concentration of biomarkers of systemic inflammation (time frame: 1 hour post dose; 4 weeks). 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 Mar 2020.