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The Impact of Acute Trans-resveratrol Administration on Whole Body Metabolism During Cognitive Demand.

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ClinicalTrials.gov Identifier: NCT03546075
Recruitment Status : Completed
First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Tim Eschle, Northumbria University

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.


Condition or disease Intervention/treatment Phase
Cognitive Change Dietary Supplement: Resveratrol Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of Acute Trans-resveratrol Administration on Whole Body Metabolism During Cognitive Task Performance: a Double Blind, Randomised, Placebo-controlled Investigation.
Actual Study Start Date : May 7, 2015
Actual Primary Completion Date : December 18, 2015
Actual Study Completion Date : December 18, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: 500 mg Resveratrol Dietary Supplement: Resveratrol
Experimental: 250 mg Resveratrol Dietary Supplement: Resveratrol
Placebo Comparator: Placebo Other: Placebo



Primary Outcome Measures :
  1. Cognitive performance [ Time Frame: 1 Hour ]
    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.

  2. Whole body metabolism [ Time Frame: 1 Hour ]
    Whole body energy expenditure was measured via indirect calorimetry and was reported in calories burned per minute (Kcal / min).

  3. Fuel Oxidisation [ Time Frame: 1 Hour ]
    Fuel oxidation was measured via indirect calorimetry and examined the rate of carbohydrate and fat oxidisation (both in grams per minute (g / min)).


Secondary Outcome Measures :
  1. Pulmonary gases [ Time Frame: 1 Hour ]
    An on-line gas analysis system was used to measure oxygen intake and carbon dioxide excretion (both in litres per minute (L / min)) from the participant's expired pulmonary air.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants who were able to give informed consent.
  • Those who didn't meet any of the exclusion criteria.
  • Those who took hormonal contraception (e.g. the pill, coil, implant, etc.) were still allowed to participate in the current study.

Exclusion Criteria:

  • 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.
  • Participants who have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total).
  • Participants with any food intolerances/sensitivities.
  • Participants with a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g., iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation.
  • Female participants who are currently pregnant, lactating or seeking to become pregnant.

Responsible Party: Tim Eschle, Principal investigator, Northumbria University
ClinicalTrials.gov Identifier: NCT03546075     History of Changes
Other Study ID Numbers: 42BB1
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tim Eschle, Northumbria University:
Cognition
Resveratrol
Whole body metabolism

Additional relevant MeSH terms:
Resveratrol
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents