NCT03135314

Brief 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. 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). 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

April 19, 2017

Last Update Submit

May 19, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • prefrontal/muscular oxygenation

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

  • work (kj) performed during 20 minute time trial

    after 7 days of intake

Secondary Outcomes (2)

  • Flow mediated dilation

    after 6 days of intake

  • oxidative stress

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

Study Arms (4)

Hypoxia Cocoa flavanol

ACTIVE COMPARATOR

Exercise or cognitive test in (acute) hypoxic condition after 7 days of cocoa flavanol intake

Dietary Supplement: cocoa flavanol

Hypoxia Placebo

PLACEBO COMPARATOR

Exercise or cognitive test in (acute) hypoxic condition after 7 days of placebo intake

Dietary Supplement: placebo

Normoxia Cocoa flavanol

ACTIVE COMPARATOR

Exercise or cognitive test in normoxic condition after 7 days of cocoa flavanol intake

Dietary Supplement: cocoa flavanol

normoxia placebo

PLACEBO COMPARATOR

Exercise or cognitive test in normoxic condition after 7 days of placebo intake

Dietary Supplement: placebo

Interventions

cocoa flavanolDIETARY_SUPPLEMENT

7 days intake of cocoa flavanol supplement (naturex)

Hypoxia Cocoa flavanolNormoxia Cocoa flavanol
placeboDIETARY_SUPPLEMENT

7 days of placebo intake

Hypoxia Placebonormoxia placebo

Eligibility Criteria

Age18 Years - 36 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • train more than 10 hours/week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator at Human Physiology research group

Study Record Dates

First Submitted

April 19, 2017

First Posted

May 1, 2017

Study Start

May 2, 2016

Primary Completion

July 30, 2016

Study Completion

July 30, 2016

Last Updated

May 22, 2017

Record last verified: 2017-05