Clinical trial NCT04314739: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Mood
Systemic Inflammation
Keywords: Resveratrol
Polyphenol
Cognition
Mood
Inflammation
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Evolva SA
First posted: 2020-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change from baseline concentration of biomarkers of systemic inflammation
timeFrame: 1 hour post dose; 4 weeks
Secondary outcomes:
measure: Acute changes in cognitive task performance
timeFrame: 40 minutes post dose
measure: Interim changes in cognitive task performance
timeFrame: Day 7; Day 14; Day 21; Day 28
measure: Chronic changes in cognitive task performance
timeFrame: 4 weeks
measure: Acute changes in mood
timeFrame: 40 mins post dose
measure: Interim changes in mood
timeFrame: Day 7; Day 14; Day 21; Day 28
measure: Chronic changes in mood
timeFrame: 4 weeks
measure: Acute changes in concentration of plasma and serum biomarkers
timeFrame: 1 hour post dose
measure: Chronic changes in concentration of plasma and serum biomarkers
timeFrame: 4 weeks
measure: Acute and chronic changes in blood pressure
timeFrame: 1 hour post dose, 4 weeks
measure: Acute and chronic changes in heart rate
timeFrame: 1 hour post dose, 4 weeks
measure: Changes in weight and Body Mass Index (BMI)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne And Wear
Study officials:
affiliation: Northumbria University
name: Emma L Wightman, Dr
role: PRINCIPAL_INVESTIGATOR
References: