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NCT03135314
Cocoa Flavanol Intake and Exercise in Hypoxia
NA trial testing cocoa flavanol in Hypoxia, Altitude in 15 participants. Completed in 30 July 2016.
30 July 2016
Quick facts
| Lead sponsor | Vrije Universiteit Brussel |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 2 May 2016 |
| Primary completion | 30 July 2016 |
| Estimated completion | 30 July 2016 |
Drugs / interventions tested
- cocoa flavanol
- placebo
Conditions studied
- Hypoxia, Altitude — all drugs for Hypoxia, Altitude →
Sponsor
Vrije Universiteit Brussel — full company profile →
Who can join
Adults 18 to 36, male only, with Hypoxia, Altitude. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03135314
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03135314 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vrije Universiteit Brussel
- Last refreshed: 22 May 2017
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