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
About this trial
This is an interventional other trial for Hypoxia, Altitude
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
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
NCT ID
NCT03135314
First Posted
April 19, 2017
Last Updated
May 19, 2017
Sponsor
Vrije Universiteit Brussel
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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