The Effects of Resveratrol Supplementation on Cognition, Cerebral Blood Flow, Microbiota and Systemic Inflammation.

March 16, 2020 updated by: EllenSmith, Northumbria University

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.

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 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 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.
110

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

31 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
  • 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)

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: Double

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.
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 three months.
Experimental: 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 three months.
Other Names:
  • Veri-teTM Resveratrol

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 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.
45 minutes, 240 minutes, 12 weeks
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.
45 minutes, 240 minutes, 12 weeks
Gut microbiota
Time Frame: 12 weeks
Changes in gut microbiota communities, quantified using 16S ribosomal ribonucleic acid (rRNA) gene community analysis.
12 weeks
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.
5 hours, 12 weeks
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.
12 weeks
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).
115-190 minutes, 12 weeks
Change from baseline deoxygenated haemoglobin CBF measurement
Time Frame: 115-190 minutes, 12 weeks
CBF of the frontal cortex measured using qNIRS.
115-190 minutes, 12 weeks
Change from baseline oxygen saturation CBF measurement
Time Frame: 115-190 minutes, 12 weeks
CBF of the frontal cortex measured using qNIRS.
115-190 minutes, 12 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
Change from baseline Blood Pressure
Time Frame: 45 minutes, 240 minutes, 12 weeks
Systolic and diastolic blood pressure will be taken after each cognitive assessment (measured in mm Hg).
45 minutes, 240 minutes, 12 weeks
Change from baseline Heart Rate
Time Frame: 45 minutes, 240 minutes, 12 weeks
Heart rate will be measured after each cognitive assessment (measured in BPM).
45 minutes, 240 minutes, 12 weeks
Change from baseline subjective mood score
Time Frame: 240 minutes, 12 weeks
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.
240 minutes, 12 weeks
Weight change and BMI
Time Frame: 12 weeks
Change in weight and BMI between visits
12 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 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.
February 6, 2018

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.
July 13, 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.
July 13, 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).
February 7, 2018

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.
February 21, 2018

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.
February 27, 2018

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 17, 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 16, 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, 2020

More Information

Terms related to this study

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.
  • 52P6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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