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

NCT ID: NCT03100019

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-13
• Study Completion Date: 2015-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Resveratrol Hypoxia

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

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Placebo Hypoxia

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Resveratrol Normoxia

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

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Placebo Normoixa

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants who gave informed consent.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Tim Eschle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

22AX1

Identifier Type: -

Identifier Source: org_study_id