Ketogenic DietingICKDNCT05603689
Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude
A study testing Isocaloric ketogenic diet in people with Ketogenic Dieting and Altitude Hypoxia, run by Clinique Romande de Readaptation at 1 site in Switzerland.
Trial summary
A ketogenic diet (KD) reduces daily carbohydrates (CHOs) ingestion by replacing most calories with fat. KD is of increasing interest among athletes because it may increase their maximal oxygen uptake (VO2max), the principal performance limitation at high altitudes. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Dieting, Altitude Hypoxia, Physical Activity
- What is being tested?
- Isocaloric ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreational mountaineers
- Familiarity with altitude (>2500 m above sea level) and males/females 20 to 45 years old.
Who cannot join
- high training load (such as professional athletes) or new planned training
- dietary restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Four-week Isocaloric Ketogenic Diet on Physical Performance at Very High Altitude: a Pilot Study
A ketogenic diet (KD) reduces daily carbohydrates (CHOs) ingestion by replacing most calories with fat. KD is of increasing interest among athletes because it may increase their maximal oxygen uptake (VO2max), the principal performance limitation at high altitudes. The investigators examined the tolerance of a 4-week isocaloric KD (ICKD) under simulated hypoxia and the possibility of evaluating ICKD performance benefits with a maximal graded exercise bike test under hypoxia and collected data on the effect of the diet on performance markers and arterial blood gases.
Read the detailed description
In a randomised single-blind cross-over model, 6 recreational mountaineers (age 24 to 44 years) will complete a 4-week ICKD followed or preceded by a 4-week habitual mixed western diet (HD). Performance parameters (VO2max, lactate threshold [LT], peak power [Ppeak]) and arterial blood gases (PaO2, PaCO2, pH, HCO3-) will be measured at baseline under two conditions (normoxia and hypoxia) as well as after a 4-week HD and 4-week ICKD under the hypoxic condition.
- Conditions
- Ketogenic Dieting, Altitude Hypoxia, Physical Activity
- Being tested
- Isocaloric ketogenic diet
- Medical subject headings
- Altitude Sickness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isocaloric ketogenic dietDietary supplement
The ICKD definition was based on the works of Sansone (2018) and Trimboli (2020). We defined ICKD as a daily CHOs ingestion < 30 to 50 g.d-1, without any limitation in fat consumption. Participants self-selected their own diet based on a list of advised and forbidden foods developed to fit the definition of ICKD. There were no instructions to limit calories.
| Study group | Role | What they receive |
|---|---|---|
| Normal diet | Active comparator | no limitations on food consumption. Receives: Dietary Supplement: Isocaloric ketogenic diet |
| Isocaloric ketogenic diet | Experimental | We defined ICKD as a daily CHOs ingestion < 30 to 50 g.d-1, without any limitation in fat consumption. Receives: Dietary Supplement: Isocaloric ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance test under hypoxic conditions
VO2max cycling test on ergometer
Measured: after 4 weeks of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ketogenic DietingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Romande de Readaptation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Lara Allet, PhD, Study director, HESso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603689
- Sponsor's protocol ID
- CRR
- Acronym
- ICKD
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiarello N, Leger B, De Riedmatten M, Rossier MF, Vuistiner P, Duc M, Rapillard A, Allet L. Effect of a four-week isocaloric ketogenic diet on physical performance at very high-altitude: a pilot study. BMC Sports Sci Med Rehabil. 2023 Mar 20;15(1):37. doi: 10.1186/s13102-023-00649-9.
PubMed 36941621
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Four-week Isocaloric Ketogenic Diet on Physical Performance at Very High Altitude: a Pilot Study
- ClinicalTrials.gov ID
- NCT05603689
- Acronym / sponsor ID
- ICKD / CRR
- Conditions
- Ketogenic Dieting, Altitude Hypoxia, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Clinique Romande de ReadaptationResearch network
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A ketogenic diet (KD) reduces daily carbohydrates (CHOs) ingestion by replacing most calories with fat. KD is of increasing interest among athletes because it may increase their maximal oxygen uptake (VO2max), the principal performance limitation at high altitudes. The investigators examined the tolerance of a 4-week isocaloric KD (ICKD) under simulated hypoxia and the possibility of evaluating ICKD performance benefits with a maximal graded exercise bike test under hypoxia and collected data on the effect of the diet on performance markers and arterial blood gases.
Detailed description
In a randomised single-blind cross-over model, 6 recreational mountaineers (age 24 to 44 years) will complete a 4-week ICKD followed or preceded by a 4-week habitual mixed western diet (HD). Performance parameters (VO2max, lactate threshold [LT], peak power [Ppeak]) and arterial blood gases (PaO2, PaCO2, pH, HCO3-) will be measured at baseline under two conditions (normoxia and hypoxia) as well as after a 4-week HD and 4-week ICKD under the hypoxic condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal diet | Active comparator | Dietary Supplement: Isocaloric ketogenic dietno limitations on food consumption. |
| Isocaloric ketogenic diet | Experimental | Dietary Supplement: Isocaloric ketogenic dietWe defined ICKD as a daily CHOs ingestion < 30 to 50 g.d-1, without any limitation in fat consumption. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Recreational mountaineers
- Familiarity with altitude (>2500 m above sea level) and males/females 20 to 45 years old.
Key exclusion criteria (2 listed)
- high training load (such as professional athletes) or new planned training
- dietary restrictions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isocaloric ketogenic dietThe ICKD definition was based on the works of Sansone (2018) and Trimboli (2020). We defined ICKD as a daily CHOs ingestion < 30 to 50 g.d-1, without any limitation in fat consumption. Participants self-selected their own diet based on a list of advised and forbidden foods developed to fit the definition of ICKD. There were no instructions to limit calories. | Dietary supplement | Isocaloric ketogenic diet, Normal diet |
Primary outcome
Performance test under hypoxic conditions
Time frame: after 4 weeks of diet
VO2max cycling test on ergometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 36941621Chiarello N, Leger B, De Riedmatten M, Rossier MF, Vuistiner P, Duc M, Rapillard A, Allet L. Effect of a four-week isocaloric ketogenic diet on physical performance at very high-altitude: a pilot study. BMC Sports Sci Med Rehabil. 2023 Mar 20;15(1):37. doi: 10.1186/s13102-023-00649-9.
- Individual participant dataSharing planned: No
Related trials for Ketogenic Dieting
Recruiting
Ketogenic Diet and Diabetes Demonstration Project
Type 2 Diabetes, PreDiabetes
RecruitingPhase 3
Ketogenic Diet for New-Onset Absence Epilepsy
Absence Epilepsy, Ketogenic Dieting
Active, not recruitingPhase 2/3
Effect of Nutritional Ketosis on Alcohol Metabolism
Ketoses, Metabolic, Ketogenic Dieting
Recruiting
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Lymphedema, Ketogenic Dieting
Not yet recruiting
Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling
Schizophrenia, Schizophrenia and Related Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Allet, PhD study director
HESso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isocaloric ketogenic diet in people with Ketogenic Dieting and Altitude Hypoxia, run by Clinique Romande de Readaptation at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance test under hypoxic conditions (time frame: after 4 weeks of diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.