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Hypoxia, AltitudeNCT03135314

Cocoa Flavanol Intake and Exercise in Hypoxia

A study testing cocoa flavanol in people with Hypoxia, Altitude, run by Vrije Universiteit Brussel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Not uncommonly, sports events take place or finish at high altitude, where physical and cognitive (e.g. decision-making, motor control) performance in hypoxia is determining the outcome of sports performance. Read more about this study

Who is it for?
Ages 18 to 36 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hypoxia, Altitude
What is being tested?
cocoa flavanol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
No sites listed yet
Study dates
2 May 2016to 30 Jul 2016
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 36 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • train more than 10 hours/week

Who cannot join

  • severe head injuries in the past
  • hypertensive
  • with cardiovascular disease / take medication for cardiovascular disease
  • smokers
  • take nutritional supplements
  • had stayed at high altitude (>3000m) for 3 weeks during the last 6 months

About this study

Official title: The Effect of Cocoa Flavanol Intake on Cerebral and Muscle Perfusion and Oxygenation in Hypoxia - Implications for Cognitive and Exercise Performance

Not uncommonly, sports events take place or finish at high altitude, where physical and cognitive (e.g. decision-making, motor control) performance in hypoxia is determining the outcome of sports performance. With nutritional supplements growing in popularity in the athletic and non-athletic population, research is increasingly focussing on dietary constituents which can improve cognitive and exercise performance.

Flavonoids, a subgroup of polyphenols, are a class of natural compounds found in the human diet and include subcategories of flavanols, flavonols, iso-flavones, flavones, and anthocyanidins. Intake of flavanols, found in grapes, tea, red wine, apples and especially cocoa, causes an nitric oxide (NO)-mediated vasodilatation and can improve peripheral and cerebral blood flow (CBF).

Read more

For cocoa flavanol (CF), there is evidence that both long term and acute intake can improve cognitive function, with the quantity and bioavailability of the consumed CF highly influencing its beneficial effects and with higher doses eliciting greater effects on cognition. Increased CBF following acute and chronic (3 months) CF intake has been demonstrated in healthy young subjects. Moreover, cognitive performance and mood during sustained mental efforts are improved after acute CF intake in healthy subjects and CF intake can increase prefrontal oxygenation during cognitive tasks in well-trained athletes. Moreover, CF intake is not only associated with an improved blood flow, but it might also improve exercise performance following 2 weeks of dark chocolate intake. On top of that, CF is known to have anti-oxidant properties and 2 week CF intake has been associated with reduced oxidative-stress markers following exercise.

In hypoxic conditions, arterial pressure of oxygen (PaO2) and arterial saturation of O2 (SaO2) are decreased, compromising tissue oxygen delivery. Since brain function and brain integrity are dependent on continuous oxygen supply, brain desaturation may result in an impaired cognitive function in hypoxia. The severity of the impairment is related to the extent of high altitude, with at 3000m (=14.3 % oxygen (O2); = 71% of oxygen available at sea level) psychomotor impairments being visible. Cerebral oxygenation, which can be measured by Near-infrared spectroscopy, is lowered in hypoxia.

It remains unclear whether CF intake can influence cerebral oxygenation and perfusion in hypoxic conditions and whether CF intake could (partially) counteract hypoxia-induced cognitive impairments. Therefore, the first aim of this study was to investigate whether cognitive function and prefrontal oxygenation during a mental demanding task will be impaired by hypoxic conditions (3000m altitude; 14.3% O2) and whether these impairments can be partially restored by subchronic CF intake (7 days, 900 mg/day).

Hypoxia also impairs physical performance. Hypoxia-induced reductions in cerebral oxygenation may favour central fatigue, i.e. the failure of the central nervous system to excite the motoneurons adequately, hence impairing exercise performance in hypoxic conditions. Since hypoxia also impairs oxygen delivery to muscle tissue, the decreased oxygen supply to and impaired oxidative energy production in the exercising muscle is a second factor negatively affecting exercise performance.

Besides the aforementioned effects of altitude on O2 delivery, hypoxia also results in increased oxidative stress. Oxidative stress refers to the imbalance between prooxidant and antioxidant levels in favor of prooxidants in cells and tissues and can result from diminished antioxidant levels or increased production of reactive oxygen species. The latter can be induced by both exhaustive exercise and high altitude. Since oxidative stress can be counteracted by CF, we also aim to investigate how markers of oxidative stress can be affected by CF intake by exercise in hypoxia. Therefore, the second aim of this study was to investigate possible beneficial effects of CF intake on changes in cerebral and muscle vasoreactivity and oxidative stress during exercise in hypoxia and its implications on exercise performance.

Being tested
cocoa flavanol, placebo
Medical subject headings
Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cocoa flavanolDietary supplement

    7 days intake of cocoa flavanol supplement (naturex)

  • placeboDietary supplement

    7 days of placebo intake

Study groups in NCT03135314
Study groupRoleWhat they receive
Hypoxia Cocoa flavanolActive comparatorExercise or cognitive test in (acute) hypoxic condition after 7 days of cocoa flavanol intake
Receives: Dietary Supplement: cocoa flavanol
Hypoxia PlaceboPlacebo comparatorExercise or cognitive test in (acute) hypoxic condition after 7 days of placebo intake
Receives: Dietary Supplement: placebo
Normoxia Cocoa flavanolActive comparatorExercise or cognitive test in normoxic condition after 7 days of cocoa flavanol intake
Receives: Dietary Supplement: cocoa flavanol
normoxia placeboPlacebo comparatorExercise or cognitive test in normoxic condition after 7 days of placebo intake
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prefrontal/muscular oxygenation

    Measured: change from baseline (pre-exercise) at post-exercise after 7 days of intake

  2. work (kj) performed during 20 minute time trial

    Measured: after 7 days of intake

Secondary outcomes (2)
  1. Flow mediated dilation

    Measured: after 6 days of intake

  2. oxidative stress

    Measured: change from baseline (pre-exercise) at post-exercise after 7 days of intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2017
  2. Study start2 May 2016
  3. Primary completion30 Jul 2016
  4. Study completion30 Jul 2016

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03135314
Sponsor's protocol ID
CFEH2016
Status last verified
May 2017
First submitted
19 Apr 2017
Last updated
22 May 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Decroix L, Tonoli C, Lespagnol E, Balestra C, Descat A, Drittij-Reijnders MJ, Blackwell JR, Stahl W, Jones AM, Weseler AR, Bast A, Meeusen R, Heyman E. One-week cocoa flavanol intake increases prefrontal cortex oxygenation at rest and during moderate-intensity exercise in normoxia and hypoxia. J Appl Physiol (1985). 2018 Jul 1;125(1):8-18. doi: 10.1152/japplphysiol.00055.2018. Epub 2018 Mar 15.

    PubMed 29543135

Questions about this trial

What is this clinical trial studying?

A study testing cocoa flavanol in people with Hypoxia, Altitude, run by Vrije Universiteit Brussel.

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 1 inclusion and 6 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

prefrontal/muscular oxygenation (time frame: change from baseline (pre-exercise) at post-exercise after 7 days of intake). 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?

On the ClinicalTrials.gov record for NCT03135314, which also lists 1 linked publication.

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 22 May 2017.

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