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Completed

NCT Number: NCT05603689

Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRR

Sion, 1951, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Isocaloric ketogenic diet

Dietary 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.

Primary outcomes

  1. Performance test under hypoxic conditions

    Time frame: after 4 weeks of diet

    VO2max cycling test on ergometer

Sponsors and collaborators

Lead sponsor

Clinique Romande de Readaptation

Network

Registry information

Official study title

Effect of a Four-week Isocaloric Ketogenic Diet on Physical Performance at Very High Altitude: a Pilot Study

Acronym: ICKD

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 3, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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