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

The Effects of Acute Trans-resveratrol Supplementation on Aspects of Cognitive Function and Cerebral Blood Flow, During Hypoxia and Normoxia, in Healthy, Young Humans.

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia, Brain
• Intervention / Treatment: Drug: Placebo; Dietary supplement: Resveratrol

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2014
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): April 30, 2015

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cognition; Resveratrol; Cerebral blood flow
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Hypoxia, Brain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: 22AX1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No