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NCT06097754
Intermittent Exogenous Ketosis (IEK) at High Altitude
NA trial testing Ketone ester in Ketosis in 35 participants. Status unknown.
30 October 2023
Quick facts
| Lead sponsor | Jozef Stefan Institute |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 35 |
| Start date | 18 September 2023 |
| Primary completion | 30 October 2023 |
| Estimated completion | 30 June 2024 |
| Sites | 2 locations across Belgium, Slovenia |
Drugs / interventions tested
- Ketone ester
- Placebo
Conditions studied
Sponsor
Jozef Stefan Institute
Who can join
Adults 18 to 35, any sex, with Ketosis or Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Altitude-related hypoxia decreases human functional capacity, especially during exercise. Even with prolonged acclimatization, the physiological adaptations are insufficient to preserve exercise capacity, especially at higher altitudes completely. Consequently, there has been an ongoing search for various interventions to mitigate the negative effects of hypoxia on human performance and functional capacity. Interestingly, early data in rodents and humans indicate that intermittent exogenous ketosis (IEK) by ketone ester intake improves hypoxic tolerance, i.e.by facilitating muscular and neuronal energy homeostasis and reducing oxidative stress. Furthermore, there is evidence to indicate that hypoxia elevates the contribution of ketone bodies to adenosine-triphosphate (ATP) generation, substituting glucose and becoming a priority fuel for the brain. Nevertheless, it is reasonable to postulate that ketone bodies might also facilitate long-term acclimation to hypoxia by upregulation of both hypoxia-inducible factor-1α and stimulation of erythropoietin production. The present project aims to comprehensively investigate the effects of intermittent exogenous ketosis on physiological, cognitive, and functional responses to acute and sub-acute exposure to altitude/hypoxia during rest, exercise, and sleep in healthy adults. Specifically, we aim to elucidate 1) the effects of acute exogenous ketosis during submaximal and maximal intensity exercise in hypoxia, 2) the effects of exogenous ketosis on sleep architecture and quality in hypoxia, and 3) the effects of exogenous ketosis on hypoxic tolerance and sub-acute high-altitude adaptation. For this purpose, a placebo-controlled clinical trial (CT) in hypobaric hypoxia (real high altitude) corresponding to 3375 m a.s.l. (Rifugio Torino, Courmayeur, Italy) will be performed with healthy individuals to investigate both the functional effects of the tested interventions and elucidate the exact physiological, cellular, and molecular mechanisms involved in acute and chronic adaptation to hypoxia. The generated output will not only provide novel insight into the role of ketone bodies under hypoxic conditions but will also be of applied value for mountaineers and athletes competing at altitude as well as for multiple clinical diseases associated with hypoxia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06097754
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Related trials
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Trials testing the same drug.
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- NCT06846840 — Ketone Esters and Metabolism During Recovery from Endurance Exercise · NA · active not recruiting
- NCT07065864 — Ketone Esters for Optimization of Operator Performance in Hypoxia · NA · completed
Other recruiting trials for Ketosis
Currently open trials in the same condition.
- NCT06815237 — Effects of Ketone Supplement and Alcohol on Brain Metabolism · Phase 2, PHASE3 · recruiting
- NCT06338969 — The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis · NA · recruiting
- NCT05924295 — Variations in Ketone Metabolism · NA · recruiting
Other Jozef Stefan Institute trials
Trials by the same sponsor.
- NCT05764018 — Caffeine and Hypoxia During Exercise in Males and Females · NA · completed
- NCT04739904 — Hypoxia Intolerance in Preterm Individuals · completed
- NCT04579770 — Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia · NA · completed
- NCT03497871 — Personal Decision Support System for Heart Failure Management · NA · completed
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 NCT06097754 (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 Jozef Stefan Institute
- Last refreshed: 24 October 2023
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