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

NCT03100019 | Completed

• 1 other identifier: 22AX1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoxia, Brain

Keywords

Resveratrol; Cerebral blood flow; Cognition

Outcome Measures

Primary Outcomes (2)

• Cerebral blood flow

  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 hours

• Cognitive performance

  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.

  1 hour

Study Arms (4)

Resveratrol Hypoxia

EXPERIMENTAL

500mg of trans-resveratrol, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.

Dietary Supplement: Resveratrol

Placebo Hypoxia

PLACEBO COMPARATOR

Pharmaceutical grade fumed silica, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.

Drug: Placebo

Resveratrol Normoxia

EXPERIMENTAL

500mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.

Dietary Supplement: Resveratrol

Placebo Normoixa

PLACEBO COMPARATOR

Pharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.

Drug: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Resveratrol Hypoxia; Resveratrol Normoxia

Placebo DRUG

Placebo Hypoxia; Placebo Normoixa

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who gave informed consent.

You may not qualify if:

• Those who took hormonal contraception (e.g.: the pill, coil, implant, etc.) were allow to participate in the current study.
• 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.

Sponsors & Collaborators

• Northumbria University: lead

MeSH Terms

Conditions

Hypoxia, Brain

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

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: March 21, 2017
• First Posted: April 4, 2017
• Study Start: May 13, 2014
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share