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

NCT ID: NCT04314739

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2019-12-19

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.

Conditions

Cognitive Change; Mood; Systemic Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Resveratrol

500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day).

Group Type: ACTIVE_COMPARATOR

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Participants will consume one of the treatment types daily for a period of four weeks.

Placebo

Matched placebo capsules (1 capsule consumed at two timepoints each day).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will consume one of the treatment types daily for a period of four weeks.

Interventions

Resveratrol

Participants will consume one of the treatment types daily for a period of four weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will consume one of the treatment types daily for a period of four weeks.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Veri-teTM Resveratrol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Evolva SA

INDUSTRY

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma L Wightman, Dr

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Northumbria University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

52P7

Identifier Type: -

Identifier Source: org_study_id