NCT04314739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

April 1, 2019

Last Update Submit

March 17, 2020

Conditions

Keywords

ResveratrolPolyphenolCognitionMoodInflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Acute changes in cognitive task performance

    40 minutes post dose

  • Interim changes in cognitive task performance

    Day 7; Day 14; Day 21; Day 28

  • Chronic changes in cognitive task performance

    4 weeks

  • Acute changes in mood

    40 mins post dose

  • Interim changes in mood

    Day 7; Day 14; Day 21; Day 28

  • +6 more secondary outcomes

Study Arms (2)

Resveratrol

ACTIVE COMPARATOR

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

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT

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

Also known as: Veri-teTM Resveratrol
Resveratrol
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must self-assess themselves as being in good health.
  • Aged 18 to 55 at the time of giving consent

You may not qualify if:

  • Have a Body Mass Index (BMI) outside the range of 18.5-42kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Emma L Wightman, Dr

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

March 19, 2020

Study Start

March 19, 2019

Primary Completion

December 19, 2019

Study Completion

December 19, 2019

Last Updated

March 19, 2020

Record last verified: 2019-03

Locations