Clinical trial NCT03541993: The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at Stimulated Altitude.
Official title: The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at 4000 m Stimulated Altitude and at Sea Level: A Double Blind, Crossover Investigation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia, Altitude
Brain
Keywords: Resveratrol
Cerebral blood flow
Cognition
Hypoxia
Polyphenols
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Background: Vaso-active polyphenols have been proposed to enhance cognitive performance. Oral administration with the non-flavonoid polyphenol, resveratrol, has been found to modulate cerebral blood flow (CBF); yet, this has not resulted in subsequent predicted benefits to cognitive performance in young, healthy samples. It has been argued that ageing populations who are noted suffer a reduction in CBF and cognition, may possess the subtle deficits to benefit from resveratrol administration. The use of hypoxia has been previously tested by this research group to mimic the decrease in cognitive functioning associated with ageing.

Objectives: The current investigation aimed to further assess if a reduced fraction of inspired oxygen (12.7% FiO2) could provide an experimental model of aging in a young, healthy sample. Moreover, the current study also aimed to assess if resveratrol can attenuate the deficits elicited by the reduction in oxygen supply via increased CBF.

Design: This repeated measures, double blind, placebo controlled, balanced design assessed the cognitive and CBF effects of resveratrol in hypoxia (equivalent to 4000 m above sea level) and normoxia (sea level).

Methods: Twenty-four participants arrived fully fasted (except water) for 12 hours before completing a baseline measure of a cognitive task battery, and taking the treatment for the day (either 500 mg resveratrol or inert placebo). Following a 45 min absorption period, participants completed 3 full repetitions of a cognitive test battery. Changes in cerebral hemodynamics were measured by near-infrared spectroscopy throughout the full testing session.


Eligibility criteria: Inclusion Criteria:

* Individuals who provided 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 eligible to participate in the current study.

Exclusion Criteria:

* Individuals below 18 years or above 35 years old at the time of giving consent.
* Individuals with Body Mass Index outside of the range 18-35 kg/m2.
* Individuals with blood pressure greater than 140/90 HH/mg.
* Those who smoke or have smoked.
* Individuals who have been living (for more than 3 months) at an altitude of 2000 m or over within the past 6 months.
* Individuals with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety).
* Individuals with a current diagnosis of depression and/or anxiety.
* Individuals with relevant learning difficulties, dyslexia, dyscalculia or colour blindness.
* Individuals with visual impairment that cannot be corrected with glasses or contact lenses.
* Individuals with frequent migraines that require medication (more than or equal to 1 per month).
* Individuals with disorders of the blood.
* Individuals with a heart disorder.
* Individuals with a respiratory disorder that requires regular medication (Note: asthma sufferers who only take their medication occasionally/as required are eligible for this study).
* Individuals with diabetes.
* Individuals with any food intolerances/sensitivities.
* Females participants who were pregnant, seeking to become pregnant, or currently lactating.
* Individuals currently taking any prescription medications.
* Individuals who have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total).
* Individuals 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.
* Individuals with any health condition that would prevent fulfilment of the study requirements.

Primary outcomes:
measure: Cerebral blood flow
timeFrame: 2 hours
measure: Cognitive performance
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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