Cognitive Change Clinical Trial
Official title:
The Acute and Chronic Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults
NCT number | NCT04314739 |
Other study ID # | 52P7 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 19, 2019 |
Est. completion date | December 19, 2019 |
Verified date | March 2019 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 19, 2019 |
Est. primary completion date | December 19, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northumbria University | Newcastle Upon Tyne | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
Northumbria University | Evolva SA |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline concentration of biomarkers of systemic inflammation | Assessment of change from baseline: C reactive protein, tumor necrosis factor alpha and interleukin 6. | 1 hour post dose; 4 weeks | |
Secondary | 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. | 40 minutes post dose | |
Secondary | 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. | Day 7; Day 14; Day 21; Day 28 | |
Secondary | 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. | 4 weeks | |
Secondary | 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. | 40 mins post dose | |
Secondary | 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. | Day 7; Day 14; Day 21; Day 28 | |
Secondary | 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. | 4 weeks | |
Secondary | 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. | 1 hour post dose | |
Secondary | 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. | 4 weeks | |
Secondary | Acute and chronic changes in blood pressure | Systolic and diastolic blood pressure will be taken after each cognitive assessment (measured in mm Hg). | 1 hour post dose, 4 weeks | |
Secondary | Acute and chronic changes in heart rate | Heart rate will be measured after each cognitive assessment (measured in BPM). | 1 hour post dose, 4 weeks | |
Secondary | Changes in weight and Body Mass Index (BMI) | Participants weight will be recorded at testing visits and BMI will be calculated. | 4 weeks |
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