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

NCT04374409 | Completed

• 1 other identifier: ERN_17_1591
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

flavanol; cocoa; brain; oxygenation; vascular; cognition; hypercapnia; functional near-infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Cortical Blood Deoxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS)

  Change from baseline to 2 hours

• Inverse Efficiency scores in a Modified version of the Stroop Task

  2 hours post intervention

• 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

Study Arms (2)

High-flavanol Cocoa powder

EXPERIMENTAL

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

Low-flavanol Cocoa powder

ACTIVE COMPARATOR

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

Interventions

High-flavanol cocoa powder DIETARY_SUPPLEMENT

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

High-flavanol Cocoa powder

Low-flavanol cocoa powder DIETARY_SUPPLEMENT

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

Low-flavanol Cocoa powder

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead
• University of Illinois at Urbana-Champaign: collaborator

Study Sites (1)

School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catarina Rendeiro, PhD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 5, 2020
• Study Start: October 2, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)