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Supplementation of 500mg Trans-resveratrol Within Hypoxic and Normoxic Conditions, in Healthy Humans.

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ClinicalTrials.gov Identifier: NCT03100019
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Tim Eschle, Northumbria University

Brief Summary:

Objectives: Resveratrol, a non-flavonoid polyphenol, has been found to consistently modulate cerebral blood flow (CBF) following oral supplementation. Although, this has not resulted in subsequent predicted benefits to cognitive performance in young healthy populations. However, it is argued that those who suffer a reduction in CBF and cognition, such as aging populations, may benefit more from resveratrol administration.

Hypothesis: The current investigation aimed to employ a mild hypoxia as an experimental model of aging in a young healthy population, to assess if resveratrol can attenuate the deficits elicited by the reduction in oxygen supply. It was hypothesized resveratrol would module CBF, to provide a more efficient supply of oxygen to overcome any associated decreases to performance caused by the hypoxic model.

Design: This repeated measures, double blind, placebo controlled, balanced design assessed the cognitive and CBF effects of resveratrol in hypoxia (equivalent to ~2000m above sea level) and normoxia (sea level).

Methods: 24 participants arrived fully fasted (except water) for 12 hrs before completing a baseline measure of a cognitive task battery, and taking the treatment for the day. Following a 45 min absorption period, participants completed 3 full repetitions of the cognitive test battery and, if appropriate, the oxygen level was altered. Changes in CBF were measured by near-infrared spectroscopy throughout the full testing session.


Condition or disease Intervention/treatment Phase
Hypoxia, Brain Dietary Supplement: Resveratrol Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Acute Trans-resveratrol Supplementation on Aspects of Cognitive Function and Cerebral Blood Flow, During Hypoxia and Normoxia, in Healthy, Young Humans.
Actual Study Start Date : May 13, 2014
Actual Primary Completion Date : April 30, 2015
Actual Study Completion Date : April 30, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Resveratrol Hypoxia
500mg of trans-resveratrol, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.
Dietary Supplement: Resveratrol
Placebo Comparator: Placebo Hypoxia
Pharmaceutical grade fumed silica, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.
Drug: Placebo
Experimental: Resveratrol Normoxia
500mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.
Dietary Supplement: Resveratrol
Placebo Comparator: Placebo Normoixa
Pharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.
Drug: Placebo



Primary Outcome Measures :
  1. Cerebral blood flow [ Time Frame: 2 hours ]

    Cerebral heamodynamic response (of the prefrontal cortex) at rest and during task performance (all concentration change (μmol / L)).

    There are 3 outputs to this (oxygenated, de-oxygenated and total heamoglobin, detailing changes of oxygenation and de-oxygenation in the neural tissue at rest and during task performance.


  2. Cognitive performance [ Time Frame: 1 hour ]
    Participants completed a number of tasks to measure cognitive domain performance (Episodic Memory, Speed of Attention, & Accuracy of Attention), as part of a 15 minute cognitive battery. Outcomes were measured in accuracy of responses to each task (% correct), reaction time to respond to each task (in milliseconds (ms), and the number of error responses when completing each task.



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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 gave 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 allow to participate in the current study.

Exclusion Criteria:

  • Smokers.
  • People below 18 or above 35 years old at the time of giving consent
  • People with Body Mass Index outside of the range 18-35 kg/m2.
  • People with blood pressure greater than 140/90 HH/mg
  • People who have been living (for more than 3 months) at an altitude of 2000 m or over within the past 6 months.
  • People with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety).
  • People with a current diagnosis of depression and/or anxiety.
  • Participants with learning difficulties, dyslexia or colour blindness.
  • Participants with 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 a respiratory disorder that requires regular medication (Note: asthma sufferers who only take their medication occasionally/as required are eligible for this study).
  • Participants with diabetes.
  • Participants with any food intolerances/sensitivities.
  • Women who are pregnant, or seeking to become pregnant, or are currently lactating.
  • 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 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.
  • Participants with any health condition that would prevent fulfilment of the study requirements.

Responsible Party: Tim Eschle, Principal Investigator, Northumbria University
ClinicalTrials.gov Identifier: NCT03100019     History of Changes
Other Study ID Numbers: 22AX1
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Resveratrol
Cerebral blood flow
Cognition

Additional relevant MeSH terms:
Resveratrol
Hypoxia
Hypoxia, Brain
Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents