NCT01640197

Brief Summary

The effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. It is hypothesised that the effects will be different to those seen in acute supplementation. This study will look specifically at cognitive performance, cerebral blood flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It is hypothesized that these measures will be affected differently by acute and chronic supplementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_1 healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 12, 2012

Completed
Last Updated

October 19, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

July 10, 2012

Results QC Date

September 11, 2012

Last Update Submit

October 17, 2012

Conditions

Healthy

Keywords

Cognitive performanceCerebral blood flowSubjective sleepSubjective moodSubjective health

Outcome Measures

Primary Outcomes (1)

  • Chronic Modulation of Cerebral Blood Flow

    Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28.

    40- 80 minutes post- dose on day 28 of supplementation

Secondary Outcomes (6)

  • Number of Participants With Modulated Mood

    28 days

  • Number of Participants With Modulated Cognitive Performance

    28 days

  • Number of Participants With Significant Modulation of Sleep

    Day 28

  • Number of Participants With Significant Modulation of Health

    Day 28

  • Number of Participants With Significant Modulation of Blood Pressure

    28 days

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Methyl Cellulose administered in identical capsules as the active.

Other: Placebo

500mg resveratrol

ACTIVE COMPARATOR

Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.

Dietary Supplement: Resveratrol

Interventions

ResveratrolDIETARY_SUPPLEMENT

Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.

500mg resveratrol
PlaceboOTHER

Methyl Cellulose. 1 capsule taken once daily for 28 days.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Between 18-35
  • At least enrolled on undergraduate degree programme
  • Native English speaker

You may not qualify if:

  • Smoking
  • Taking other medication/ supplements
  • Pregnant/ breast feeding
  • High caffeine consumers
  • Migraine sufferers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain performance and nutrition research centre, Northumbria university

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

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Results Point of Contact

Title
Emma Wightman
Organization
Northumbria University
emma.l.wightman@northumbria.ac.uk
(+44) 0191 2437253

Study Officials

  • David O Kennedy, Professor

    Northumbria University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 13, 2012

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 19, 2012

Results First Posted

October 12, 2012

Record last verified: 2012-08

Locations

GB(1)