Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude

NCT ID: NCT05603689

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-09-23

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Normal diet

no limitations on food consumption.

Group Type: ACTIVE_COMPARATOR

Isocaloric ketogenic diet

Intervention Type: 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.

Isocaloric ketogenic diet

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

Group Type: EXPERIMENTAL

Isocaloric ketogenic diet

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinique Romande de Readaptation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lara Allet, PhD

Role: STUDY_DIRECTOR

HESso

Locations

CRR

Sion, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 36941621 (View on PubMed)

Other Identifiers

CRR

Identifier Type: -

Identifier Source: org_study_id