NCT01331382

Brief Summary

Resveratrol is associated with a plethora of physiological effects in humans, including modulation of cerebral blood flow, despite apparently poor bioavailability. This study investigated whether the physiological effects of resveratrol could be affected when co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability of resveratrol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
Last Updated

April 8, 2011

Status Verified

April 1, 2011

Enrollment Period

7 months

First QC Date

April 6, 2011

Last Update Submit

April 7, 2011

Conditions

Healthy

Keywords

ResveratrolPiperineCerebral blood flowNear- infrared spectroscopyBioavailability

Outcome Measures

Primary Outcomes (3)

  • Modulation of levels of total haemoglobin

    80 minutes following treatment administration

  • Modulation of levels of deoxygenated haemoglobin

    80 minutes following treatment administration

  • Modulation of levels of oxygenated haemoglobin

    80 minutes following treatment administration

Secondary Outcomes (1)

  • Number of participants displaying significant modulation of cognitive performance

    40-80 minutes post dose

Study Arms (3)

250mg trans- resveratrol

EXPERIMENTAL
Dietary Supplement: Trans- resveratrolOther: Placebo (silica)

250mg trans-resveratrol with 20mg piperine

EXPERIMENTAL
Dietary Supplement: Trans- resveratrolOther: Placebo (silica)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Trans- resveratrolOther: Placebo (silica)

Interventions

Trans- resveratrolDIETARY_SUPPLEMENT

All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.

250mg trans- resveratrol250mg trans-resveratrol with 20mg piperinePlacebo
Placebo (silica)OTHER

All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.

250mg trans- resveratrol250mg trans-resveratrol with 20mg piperinePlacebo

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18-35 years old
  • Healthy
  • Non-smoker

You may not qualify if:

  • Not proficient in English
  • Taking medication or herbal supplements
  • Pregnant or breast feeding
  • Heavy caffeine consumer
  • History of head trauma, migraines, learning difficulties, ADHD, gastrointestinal problems.
  • Food allergies of intolerances

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

Related Publications (1)

  • Wightman EL, Reay JL, Haskell CF, Williamson G, Dew TP, Kennedy DO. Effects of resveratrol alone or in combination with piperine on cerebral blood flow parameters and cognitive performance in human subjects: a randomised, double-blind, placebo-controlled, cross-over investigation. Br J Nutr. 2014 Jul 28;112(2):203-13. doi: 10.1017/S0007114514000737. Epub 2014 May 7.

    PMID: 24804871DERIVED

MeSH Terms

Interventions

ResveratrolSilicon Dioxide

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenolsMineralsInorganic ChemicalsOxidesOxygen CompoundsSilicon Compounds

Study Officials

  • Emma L Wightman

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 8, 2011

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

April 8, 2011

Record last verified: 2011-04

Locations

GB(1)