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Cocoa Flavanol Intake and Exercise in Hypoxia

Primary Purpose

Hypoxia, Altitude

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cocoa flavanol
placebo
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxia, Altitude

Eligibility Criteria

18 Years - 36 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • train more than 10 hours/week

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Hypoxia Cocoa flavanol

    Hypoxia Placebo

    Normoxia Cocoa flavanol

    normoxia placebo

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    prefrontal/muscular oxygenation
    work (kj) performed during 20 minute time trial

    Secondary Outcome Measures

    Flow mediated dilation
    oxidative stress

    Full Information

    First Posted
    April 19, 2017
    Last Updated
    May 19, 2017
    Sponsor
    Vrije Universiteit Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03135314
    Brief Title
    Cocoa Flavanol Intake and Exercise in Hypoxia
    Official Title
    The Effect of Cocoa Flavanol Intake on Cerebral and Muscle Perfusion and Oxygenation in Hypoxia - Implications for Cognitive and Exercise Performance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2, 2016 (Actual)
    Primary Completion Date
    July 30, 2016 (Actual)
    Study Completion Date
    July 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vrije Universiteit Brussel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxia, Altitude

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypoxia Cocoa flavanol
    Arm Type
    Active Comparator
    Arm Description
    Exercise or cognitive test in (acute) hypoxic condition after 7 days of cocoa flavanol intake
    Arm Title
    Hypoxia Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Exercise or cognitive test in (acute) hypoxic condition after 7 days of placebo intake
    Arm Title
    Normoxia Cocoa flavanol
    Arm Type
    Active Comparator
    Arm Description
    Exercise or cognitive test in normoxic condition after 7 days of cocoa flavanol intake
    Arm Title
    normoxia placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Exercise or cognitive test in normoxic condition after 7 days of placebo intake
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    cocoa flavanol
    Intervention Description
    7 days intake of cocoa flavanol supplement (naturex)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    7 days of placebo intake
    Primary Outcome Measure Information:
    Title
    prefrontal/muscular oxygenation
    Time Frame
    change from baseline (pre-exercise) at post-exercise after 7 days of intake
    Title
    work (kj) performed during 20 minute time trial
    Time Frame
    after 7 days of intake
    Secondary Outcome Measure Information:
    Title
    Flow mediated dilation
    Time Frame
    after 6 days of intake
    Title
    oxidative stress
    Time Frame
    change from baseline (pre-exercise) at post-exercise after 7 days of intake

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    36 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: train more than 10 hours/week Exclusion Criteria: 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29543135
    Citation
    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. Erratum In: J Appl Physiol (1985). 2018 Aug 1;125(2):685.
    Results Reference
    derived

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    Cocoa Flavanol Intake and Exercise in Hypoxia

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