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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05603689
Other study ID # CRR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 23, 2022

Study information

Verified date October 2022
Source Clinique Romande de Readaptation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date September 23, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Switzerland CRR Sion

Sponsors (1)

Lead Sponsor Collaborator
Clinique Romande de Readaptation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance test under hypoxic conditions VO2max cycling test on ergometer after 4 weeks of diet
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