Cognitive Change Clinical Trial
Official title:
The Impact of Acute Trans-resveratrol Administration on Whole Body Metabolism During Cognitive Task Performance: a Double Blind, Randomised, Placebo-controlled Investigation.
NCT number | NCT03546075 |
Other study ID # | 42BB1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2015 |
Est. completion date | December 18, 2015 |
Verified date | June 2018 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Increased cerebral vaso-dilation during cognitive demand is hypothesised to
improve cognitive performance due to an improved micronutrient status. Despite previous
research demonstrating that oral resveratrol can modulate cerebral haemodynamics, this has
not translated into expected improvements to cognitive performance in young, healthy
populations. As the brain is the most metabolic organ in the body, even subtle changes to
fuel utilization and overall energy expenditure are detectable during cognitive demand. The
measurement of both overall energy expenditure and fuel utilization may provide further
insight to the effects of resveratrol and whether oral supplementation of this polyphenol can
provide clear, cognitive benefits in a young, healthy sample.
Objectives: The current study investigated the metabolic consequences of resveratrol on whole
body metabolism and fuel oxidisation during cognitive performance.
Methods: This repeated measures, double blind, placebo controlled, balanced design required
participants (N=24 for metabolic activity & N=26 for cognitive outcomes) to complete a serial
subtraction demand battery at baseline, 45 minutes, 2 and 3 hours following 500 mg, 250 mg
trans-resveratrol or inert placebo, on three separate occasions whilst connected to an
on-line gas analysis system.
Status | Completed |
Enrollment | 27 |
Est. completion date | December 18, 2015 |
Est. primary completion date | December 18, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Participants who were able to give 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 still allowed to participate in the current study. Exclusion Criteria: - Participants who smoke. - Participants below the age of 18 years or above 35 years at the time of giving consent to in role in the current study. - Participants with Body Mass Index outside the range of 18-35 kg/m2. - Participants with blood pressure greater than 140/90 HH/mg. - Participants with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety). - Participants with a current diagnosis of depression and / or anxiety. - Participants with learning difficulties: dyslexia, dyscalculia or colour blindness. - Participants with a 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 diabetes. - Participants with a respiratory disorder that requires regular medication (Note: asthma sufferers who only take their medication occasionally/as required were eligible for this study). - 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 any food intolerances/sensitivities. - 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. - Female participants who are currently pregnant, lactating or seeking to become pregnant. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Northumbria University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive performance | Participants completed three Serial subtraction tasks (Serial 3, 7 & 17). Outcomes measured from all three of these tasks were the number correct entries and number of errors. The addition of the two outcomes can also provide a 'total' number of responses entered. | 1 Hour | |
Primary | Whole body metabolism | Whole body energy expenditure was measured via indirect calorimetry and was reported in calories burned per minute (Kcal / min). | 1 Hour | |
Primary | Fuel Oxidisation | Fuel oxidation was measured via indirect calorimetry and examined the rate of carbohydrate and fat oxidisation (both in grams per minute (g / min)). | 1 Hour | |
Secondary | Pulmonary gases | An on-line gas analysis system was used to measure oxygen intake and carbon dioxide excretion (both in litres per minute (L / min)) from the participant's expired pulmonary air. | 1 Hour |
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