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

Sponsor

University of Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT04374409

Collaborator

University of Illinois at Urbana-Champaign (Other)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: High-flavanol cocoa powder Dietary Supplement: Low-flavanol cocoa powder	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Oct 2, 2018

Actual Primary Completion Date :

Dec 12, 2018

Actual Study Completion Date :

Dec 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-flavanol Cocoa powder Dietary supplement: single serving of a high-flavanol cocoa powder containing 150 mg of (-)-epicatechin and 35.5 mg of (+)-catechin	Dietary Supplement: High-flavanol cocoa powder Non-alkalized fat-reduced cocoa powder (Natural Acticoa)
Active Comparator: Low-flavanol Cocoa powder Dietary supplement: single serving of a low-flavanol cocoa powder intervention containing < 4 mg of (-)-epicatechin and (+)-catechin and matched as best as possible for macronutrients and micronutrients, such as caffeine and theobromine.	Dietary Supplement: Low-flavanol cocoa powder Alkalized fat-reduced cocoa powder (10/12 DDP Royal Dutch)

Arm

Intervention/Treatment

Experimental: High-flavanol Cocoa powder

Dietary supplement: single serving of a high-flavanol cocoa powder containing 150 mg of (-)-epicatechin and 35.5 mg of (+)-catechin

Dietary Supplement: High-flavanol cocoa powder

Non-alkalized fat-reduced cocoa powder (Natural Acticoa)

Active Comparator: Low-flavanol Cocoa powder

Dietary supplement: single serving of a low-flavanol cocoa powder intervention containing < 4 mg of (-)-epicatechin and (+)-catechin and matched as best as possible for macronutrients and micronutrients, such as caffeine and theobromine.

Dietary Supplement: Low-flavanol cocoa powder

Alkalized fat-reduced cocoa powder (10/12 DDP Royal Dutch)

Outcome Measures

Primary Outcome Measures

Cortical Blood Oxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS) [Change from baseline to 2 hours]
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)
Time to reach 90% of maximum cortical blood oxygenation during hypercapnia using functional near-infrared spectroscopy (fNIRS) [Change from baseline to 2 hours]
Time to reach 90% of maximum oxygenated haemoglobin in the frontal cortical regions of the brain during the 5% carbon-dioxide breathing challenge

Secondary Outcome Measures

Cortical Blood Deoxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS) [Change from baseline to 2 hours]
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)
Inverse Efficiency scores in a Modified version of the Stroop Task [2 hours post intervention]
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.
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).. [Change from baseline to 2 hours]
FMD of the brachial artery