ICKD: Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude

Sponsor

Clinique Romande de Readaptation (Other)

Overall Status

Completed

CT.gov ID

NCT05603689

Collaborator

(none)

Enrollment

Location

Arms

24.7

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ketogenic Dieting Altitude Hypoxia Physical Activity	Dietary Supplement: Isocaloric ketogenic diet	N/A

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

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Normal diet no limitations on food consumption.	Dietary Supplement: Isocaloric 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.
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 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.

Arm

Intervention/Treatment

Active Comparator: Normal diet

no limitations on food consumption.

Dietary Supplement: Isocaloric 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.

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

Outcome Measures

Primary Outcome Measures

Performance test under hypoxic conditions [after 4 weeks of diet]
VO2max cycling test on ergometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRR	Sion		Switzerland	1951

Sponsors and Collaborators

Clinique Romande de Readaptation

Investigators

Study Director: Lara Allet, PhD, HESso

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clinique Romande de Readaptation

ClinicalTrials.gov Identifier:

NCT05603689

Other Study ID Numbers:

First Posted:

Nov 3, 2022

Last Update Posted:

Nov 3, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Altitude Sickness

Hypoxia

Study Results

No Results Posted as of Nov 3, 2022