The Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults

March 17, 2020 updated by: Northumbria University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
        • Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must self-assess themselves as being in good health.
  • Aged 18 to 55 at the time of giving consent

Exclusion Criteria:

  • Have a Body Mass Index (BMI) outside the range of 18.5-42kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Resveratrol
500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day).
Dietary supplement: Resveratrol
Participants will consume one of the treatment types daily for a period of four weeks.
Other Names:
  • Veri-teTM Resveratrol
Placebo Comparator: Placebo
Matched placebo capsules (1 capsule consumed at two timepoints each day).
Dietary supplement: Placebo
Participants will consume one of the treatment types daily for a period of four weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 hour post dose; 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute changes in cognitive task performance
Time Frame: 40 minutes post dose
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.
40 minutes post dose
Interim changes in cognitive task performance
Time Frame: Day 7; Day 14; Day 21; Day 28
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.
Day 7; Day 14; Day 21; Day 28
Chronic changes in cognitive task performance
Time Frame: 4 weeks
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.
4 weeks
Acute changes in mood
Time Frame: 40 mins post dose
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.
40 mins post dose
Interim changes in mood
Time Frame: Day 7; Day 14; Day 21; Day 28
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.
Day 7; Day 14; Day 21; Day 28
Chronic changes in mood
Time Frame: 4 weeks
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.
4 weeks
Acute changes in concentration of plasma and serum biomarkers
Time Frame: 1 hour post dose
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.
1 hour post dose
Chronic changes in concentration of plasma and serum biomarkers
Time Frame: 4 weeks
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.
4 weeks
Acute and chronic changes in blood pressure
Time Frame: 1 hour post dose, 4 weeks
Systolic and diastolic blood pressure will be taken after each cognitive assessment (measured in mm Hg).
1 hour post dose, 4 weeks
Acute and chronic changes in heart rate
Time Frame: 1 hour post dose, 4 weeks
Heart rate will be measured after each cognitive assessment (measured in BPM).
1 hour post dose, 4 weeks
Changes in weight and Body Mass Index (BMI)
Time Frame: 4 weeks
Participants weight will be recorded at testing visits and BMI will be calculated.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Evolva SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emma L Wightman, Dr, Northumbria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 52P7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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