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CompletedNCT05603689ICKDUpdated Nov 3, 2022

Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude

An interventional study of Isocaloric ketogenic diet in Ketogenic Dieting, Altitude Hypoxia and Physical Activity, sponsored by Clinique Romande de Readaptation. Completed at 1 site in Switzerland. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.

Sponsored by Clinique Romande de Readaptation · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2020, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ketogenic Dieting
  • Altitude Hypoxia
  • Physical Activity
03

In context

Altitude Sickness

216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.

This study's enrollment of 8 is below the median of 34 across 178 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Clinique Romande de Readaptation is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Recreational mountaineers
  • Familiarity with altitude (>2500 m above sea level) and males/females 20 to 45 years old.

Exclusion criteria

Exclusion Criteria:

  • high training load (such as professional athletes) or new planned training
  • dietary restrictions.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    Normal diet

    no limitations on food consumption.

    Dietary Supplement: Isocaloric ketogenic diet

  • Experimental
    Isocaloric ketogenic diet

    We defined ICKD as a daily CHOs ingestion \< 30 to 50 g.d-1, without any limitation in fat consumption.

    Dietary Supplement: Isocaloric ketogenic diet

Interventions

  • Dietary supplementIsocaloric ketogenic diet

    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.

06

What researchers measure

Primary outcomes

  1. Performance test under hypoxic conditions

    VO2max cycling test on ergometer

    Time frame: after 4 weeks of diet

07

Study locations

1 site
  • CRR
    Sion, 1951, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05603689
Lead sponsor
Clinique Romande de Readaptation
Responsible party
Sponsor
First posted
Nov 3, 2022
Start date
Sep 1, 2020
Primary completion
Sep 1, 2021
Completion
Sep 23, 2022
Last update
Nov 3, 2022

Study contacts

Lara Allet, PhD
study director · HESso

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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