NCT05603689

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 26, 2022

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance test under hypoxic conditions

    VO2max cycling test on ergometer

    after 4 weeks of diet

Study Arms (2)

Normal diet

ACTIVE COMPARATOR

no limitations on food consumption.

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.

Dietary Supplement: Isocaloric ketogenic diet

Interventions

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.

Isocaloric ketogenic dietNormal diet

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRR

Sion, 1951, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Altitude SicknessMotor Activity

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesBehavior

Study Officials

  • Lara Allet, PhD

    HESso

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 3, 2022

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 23, 2022

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations