The Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults
Primary Purpose
Cognitive Change, Mood, Systemic Inflammation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
About this trial
This is an interventional other trial for Cognitive Change focused on measuring Resveratrol, Polyphenol, Cognition, Mood, Inflammation
Eligibility Criteria
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
Sites / Locations
- Northumbria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Resveratrol
Placebo
Arm Description
500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day).
Matched placebo capsules (1 capsule consumed at two timepoints each day).
Outcomes
Primary Outcome Measures
Change from baseline concentration of biomarkers of systemic inflammation
Assessment of change from baseline: C reactive protein, tumor necrosis factor alpha and interleukin 6.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Acute and chronic changes in blood pressure
Systolic and diastolic blood pressure will be taken after each cognitive assessment (measured in mm Hg).
Acute and chronic changes in heart rate
Heart rate will be measured after each cognitive assessment (measured in BPM).
Changes in weight and Body Mass Index (BMI)
Participants weight will be recorded at testing visits and BMI will be calculated.
Full Information
NCT ID
NCT04314739
First Posted
April 1, 2019
Last Updated
March 17, 2020
Sponsor
Northumbria University
Collaborators
Evolva SA
1. Study Identification
Unique Protocol Identification Number
NCT04314739
Brief Title
The Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults
Official Title
The Acute and Chronic Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northumbria University
Collaborators
Evolva SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Mood, Systemic Inflammation
Keywords
Resveratrol, Polyphenol, Cognition, Mood, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resveratrol
Arm Type
Active Comparator
Arm Description
500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo capsules (1 capsule consumed at two timepoints each day).
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
Veri-teTM Resveratrol
Intervention Description
Participants will consume one of the treatment types daily for a period of four weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants will consume one of the treatment types daily for a period of four weeks.
Primary Outcome Measure Information:
Title
Change from baseline concentration of biomarkers of systemic inflammation
Description
Assessment of change from baseline: C reactive protein, tumor necrosis factor alpha and interleukin 6.
Time Frame
1 hour post dose; 4 weeks
Secondary Outcome Measure Information:
Title
Acute changes in cognitive task performance
Description
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.
Time Frame
40 minutes post dose
Title
Interim changes in cognitive task performance
Description
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.
Time Frame
Day 7; Day 14; Day 21; Day 28
Title
Chronic changes in cognitive task performance
Description
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.
Time Frame
4 weeks
Title
Acute changes in mood
Description
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.
Time Frame
40 mins post dose
Title
Interim changes in mood
Description
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.
Time Frame
Day 7; Day 14; Day 21; Day 28
Title
Chronic changes in mood
Description
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.
Time Frame
4 weeks
Title
Acute changes in concentration of plasma and serum biomarkers
Description
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.
Time Frame
1 hour post dose
Title
Chronic changes in concentration of plasma and serum biomarkers
Description
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.
Time Frame
4 weeks
Title
Acute and chronic changes in blood pressure
Description
Systolic and diastolic blood pressure will be taken after each cognitive assessment (measured in mm Hg).
Time Frame
1 hour post dose, 4 weeks
Title
Acute and chronic changes in heart rate
Description
Heart rate will be measured after each cognitive assessment (measured in BPM).
Time Frame
1 hour post dose, 4 weeks
Title
Changes in weight and Body Mass Index (BMI)
Description
Participants weight will be recorded at testing visits and BMI will be calculated.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma L Wightman, Dr
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria University
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults
We'll reach out to this number within 24 hrs