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

NCT ID: NCT04374409

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2018-12-12

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

High-flavanol cocoa powder

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: ACTIVE_COMPARATOR

Low-flavanol cocoa powder

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

High-flavanol cocoa powder

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

Intervention Type: DIETARY_SUPPLEMENT

Low-flavanol cocoa powder

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Catarina Rendeiro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catarina Rendeiro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

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

Birmingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

ERN_17_1591

Identifier Type: -

Identifier Source: org_study_id