Effects of Acute Intake of Flavanols on Cerebral Oxygenation and Cognition in Young Male Adults

Healthy Clinical Trial

Official title:

A Placebo-controlled, Randomized, Double-masked, Cross-over Acute Intervention Study Investigating the Effects of Flavanols on Cerebral Oxygenation and Cognition in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374409
• Other study ID #: ERN_17_1591
• Status: Completed
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: May 2020
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the impact of one acute dose of cocoa flavanols on brain oxygenation during a hypercapnia challenge, as well as impact on cognitive performance in young healthy males. It further assesses the impact of flavanols on peripheral vascular function, as measured by brachial Flow-mediated dilation (FMD). All participants received a high-flavanol cocoa intervention (185.5 mg of flavanols (-)-epicatechin and (+)- catechin) and a low-flavanol cocoa intervention (< 4 mg of flavanols). It is hypothesized that the high-flavanol intervention increases cerebral oxygenation during hypercapnia and vascular function in comparison to the low-flavanol intervention.

Description:

Cocoa flavanols have been shown to be protective against vascular disease in humans, as evidenced by improvements in peripheral endothelial function (as measured by brachial Flow-mediated dilatation, FMD). There is also emerging evidence suggesting that flavanol-rich diets protect against cognitive aging, but mechanisms remain elusive. In this study the investigators suggest that such mechanisms might be associated with benefits within the brain vasculature. The aim of the present study was therefore to determine whether intake of flavanols enhances cerebral oxygenation in frontal cortical areas of the brain during a hypercapnia challenge (which is a well-established biomarker of vascular reactivity in the brain) to a greater extent than a low-flavanol intervention in young healthy adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male

• 18-45 years old

Exclusion Criteria:

• smokers

• hypertensive

• with history of cerebrovascular, cardiovascular or respiratory disease

• allergies or intolerances to ingredients present in cocoa powders

• taking long-term medication (e.g., hyperlipidaemia)

• on antibiotics for the previous 3 months before enrollment

• suffering from blood-clotting disorders

• known infections at the time of the study

• on a weight-reducing regimen

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• High-flavanol cocoa powder
Non-alkalized fat-reduced cocoa powder (Natural Acticoa)
• Low-flavanol cocoa powder
Alkalized fat-reduced cocoa powder (10/12 DDP Royal Dutch)

Locations

Country	Name	City	State
United Kingdom	School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical Blood Oxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS)	Cerebral oxygenated haemoglobin maximum levels in the frontal cortical regions of the brain during the 5% carbon-dioxide breathing challenge (average across minutes 3 and 4 of breathing challenge)	Change from baseline to 2 hours
Primary	Time to reach 90% of maximum cortical blood oxygenation during hypercapnia using functional near-infrared spectroscopy (fNIRS)	Time to reach 90% of maximum oxygenated haemoglobin in the frontal cortical regions of the brain during the 5% carbon-dioxide breathing challenge	Change from baseline to 2 hours
Secondary	Cortical Blood Deoxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS)	Cerebral deoxygenated haemoglobin minimal levels in the frontal cortical regions of the brain during the 5% carbon-dioxide breathing challenge (average across minutes 3 and 4 of breathing challenge)	Change from baseline to 2 hours
Secondary	Inverse Efficiency scores in a Modified version of the Stroop Task	The modified Stroop included task blocks (designated as Colour match; Word match; Stroop and Double Stroop) of increasing difficulty so that performance could be compared between simple and more demanding tasks. Reaction time and accuracy of choice were recorded to estimate inverse efficiency scores (in seconds). Higher 'inverse efficiency scores' reflect worse performance on the task, whilst lower scores reflects better performance.	2 hours post intervention
Secondary	Flow-mediated dilatation (FMD) of the brachial artery using ultrasound (expressed as % FMD: change in brachial diameter from baseline to peak dilation following 5 minutes of arterial occlusion)..	FMD of the brachial artery	Change from baseline to 2 hours