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NCT04579770
Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia
NA trial testing Ketone ester in Exercise in 14 participants. Completed in 15 December 2020.
5 December 2020
Quick facts
| Lead sponsor | Jozef Stefan Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 14 |
| Start date | 4 November 2020 |
| Primary completion | 5 December 2020 |
| Estimated completion | 15 December 2020 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Ketone ester
- Sodium bicarbonate (Sodium Bicarbonate) — full drug profile →
- Placebo
Conditions studied
Sponsor
Jozef Stefan Institute
Who can join
Adults 18 to 35, male only, with Exercise or Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. Ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). To-date effects of ketones have only been investigated in normoxia and the data in hypoxia is lacking. Hence, we want to investigate the effect of oral ketone ester intake with and without additional sodium bicarbonate (NaHCO3) ingestion on i) blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic conditions. Information obtained via this study should provide valuable information with regard to optimisation of exercise training and athletic performance, and more importantly, provide pioneering insight on the metabolic and physiological responses to ketosis under hypoxic conditions.
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 NCT04579770
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Ketone ester
Trials testing the same drug.
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- NCT06645847 — Targeting Aging With a Ketone Ester for Function in Frailty · NA · recruiting
- NCT07087093 — Effects of Ketone Esters on Circulating Senescent T Lymphocytes (T Cells) and Inflammation Levels in the Elderly · NA · recruiting
- NCT06846840 — Ketone Esters and Metabolism During Recovery from Endurance Exercise · NA · active not recruiting
- NCT06097754 — Intermittent Exogenous Ketosis (IEK) at High Altitude · NA · unknown
Other recruiting trials for Exercise
Currently open trials in the same condition.
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- NCT07479940 — Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters · NA · active not recruiting
- NCT07498530 — Virtual Assistant for Exercise Adherence in Older ADULTS · NA · recruiting
- NCT07426172 — Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism. · NA · recruiting
- NCT07276477 — Inspiratory Muscle Training After Stroke · NA · recruiting
Other Jozef Stefan Institute trials
Trials by the same sponsor.
- NCT06097754 — Intermittent Exogenous Ketosis (IEK) at High Altitude · NA · unknown
- NCT05764018 — Caffeine and Hypoxia During Exercise in Males and Females · NA · completed
- NCT04739904 — Hypoxia Intolerance in Preterm Individuals · 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 NCT04579770 (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: 9 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04579770.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing