HealthyNCT04374409
Effects of Acute Intake of Flavanols on Cerebral Oxygenation and Cognition in Young Male Adults
A study testing High-flavanol cocoa powder and Low-flavanol cocoa powder in people with Healthy, run by University of Birmingham at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-flavanol cocoa powder and Low-flavanol cocoa powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2018to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-45 years old
Who cannot join
- 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
Show all 9Show fewer
- suffering from blood-clotting disorders
- known infections at the time of the study
- on a weight-reducing regimen
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham
Birmingham, B15 2TT
About this study
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
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.
Read the 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
- Being tested
- High-flavanol cocoa powder, Low-flavanol cocoa powder
- Keywords
- flavanol, cocoa, brain, oxygenation, vascular, cognition, hypercapnia, functional near-infrared spectroscopy
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flavanol cocoa powderDietary supplement
Non-alkalized fat-reduced cocoa powder (Natural Acticoa)
Low-flavanol cocoa powderDietary supplement
Alkalized fat-reduced cocoa powder (10/12 DDP Royal Dutch)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Dietary Supplement: Low-flavanol cocoa powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Change from baseline to 2 hours
Secondary outcomes (3)
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)
Measured: Change from baseline to 2 hours
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.
Measured: 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)..
FMD of the brachial artery
Measured: Change from baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start2 Oct 2018
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Catarina Rendeiro, University of Birmingham
- Investigators
- Catarina Rendeiro, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374409
- Sponsor's protocol ID
- ERN_17_1591
- Status last verified
- May 2020
- First submitted
- 28 Apr 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04374409
- Acronym / sponsor ID
- ERN_17_1591
- Conditions
- Healthy
- Keywords
- flavanol, cocoa, brain, oxygenation, vascular, cognition, hypercapnia, functional near-infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flavanol Cocoa powder | Experimental | Dietary Supplement: High-flavanol cocoa powderDietary supplement: single serving of a high-flavanol cocoa powder containing 150 mg of (-)-epicatechin and 35.5 mg of (+)-catechin |
| Low-flavanol Cocoa powder | Active comparator | Dietary Supplement: Low-flavanol cocoa powderDietary 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male
- 18-45 years old
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flavanol cocoa powderNon-alkalized fat-reduced cocoa powder (Natural Acticoa) | Dietary supplement | High-flavanol Cocoa powder |
| Low-flavanol cocoa powderAlkalized fat-reduced cocoa powder (10/12 DDP Royal Dutch) | Dietary supplement | Low-flavanol Cocoa powder |
Primary outcome
Cortical Blood Oxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS)
Time frame: 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)
Time frame: 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
3 secondary outcomes
Cortical Blood Deoxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS)
Time frame: Change from baseline to 2 hours
Inverse Efficiency scores in a Modified version of the Stroop Task
Time frame: 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)..
Time frame: Change from baseline to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Rendeiro, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flavanol cocoa powder and Low-flavanol cocoa powder in people with Healthy, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical Blood Oxygenation reactivity to hypercapnia using functional near-infrared spectroscopy (fNIRS) (time frame: Change from baseline to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.