NCT03546075

Brief Summary

Background: Increased cerebral vaso-dilation during cognitive demand is hypothesised to improve cognitive performance due to an improved micronutrient status. Despite previous research demonstrating that oral resveratrol can modulate cerebral haemodynamics, this has not translated into expected improvements to cognitive performance in young, healthy populations. As the brain is the most metabolic organ in the body, even subtle changes to fuel utilization and overall energy expenditure are detectable during cognitive demand. The measurement of both overall energy expenditure and fuel utilization may provide further insight to the effects of resveratrol and whether oral supplementation of this polyphenol can provide clear, cognitive benefits in a young, healthy sample. Objectives: The current study investigated the metabolic consequences of resveratrol on whole body metabolism and fuel oxidisation during cognitive performance. Methods: This repeated measures, double blind, placebo controlled, balanced design required participants (N=24 for metabolic activity \& N=26 for cognitive outcomes) to complete a serial subtraction demand battery at baseline, 45 minutes, 2 and 3 hours following 500 mg, 250 mg trans-resveratrol or inert placebo, on three separate occasions whilst connected to an on-line gas analysis system.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

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

May 7, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

April 9, 2018

Last Update Submit

June 4, 2018

Conditions

Keywords

CognitionResveratrolWhole body metabolism

Outcome Measures

Primary Outcomes (3)

  • Cognitive performance

    Participants completed three Serial subtraction tasks (Serial 3, 7 \& 17). Outcomes measured from all three of these tasks were the number correct entries and number of errors. The addition of the two outcomes can also provide a 'total' number of responses entered.

    1 Hour

  • Whole body metabolism

    Whole body energy expenditure was measured via indirect calorimetry and was reported in calories burned per minute (Kcal / min).

    1 Hour

  • Fuel Oxidisation

    Fuel oxidation was measured via indirect calorimetry and examined the rate of carbohydrate and fat oxidisation (both in grams per minute (g / min)).

    1 Hour

Secondary Outcomes (1)

  • Pulmonary gases

    1 Hour

Study Arms (3)

500 mg Resveratrol

EXPERIMENTAL
Dietary Supplement: Resveratrol

250 mg Resveratrol

EXPERIMENTAL
Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT
250 mg Resveratrol500 mg Resveratrol
PlaceboOTHER
Placebo

Eligibility Criteria

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

You may qualify if:

  • Participants who were able to give informed consent.

You may not qualify if:

  • Those who took hormonal contraception (e.g. the pill, coil, implant, etc.) were still allowed to participate in the current study.
  • Participants who smoke.
  • Participants below the age of 18 years or above 35 years at the time of giving consent to in role in the current study.
  • Participants with Body Mass Index outside the range of 18-35 kg/m2.
  • Participants with blood pressure greater than 140/90 HH/mg.
  • Participants with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety).
  • Participants with a current diagnosis of depression and / or anxiety.
  • Participants with learning difficulties: dyslexia, dyscalculia or colour blindness.
  • Participants with a visual impairment that cannot be corrected with glasses or contact lenses.
  • Participants with frequent migraines that require medication (more than or equal to 1 per month).
  • Participants with disorders of the blood.
  • Participants with a heart disorder.
  • Participants with diabetes.
  • Participants with a respiratory disorder that requires regular medication (Note: asthma sufferers who only take their medication occasionally/as required were eligible for this study).
  • Participants currently taking any prescription medications.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 9, 2018

First Posted

June 6, 2018

Study Start

May 7, 2015

Primary Completion

December 18, 2015

Study Completion

December 18, 2015

Last Updated

June 6, 2018

Record last verified: 2018-06