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

Primary Purpose

Ketogenic Dieting, Altitude Hypoxia, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Isocaloric ketogenic diet
Sponsored by
Clinique Romande de Readaptation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ketogenic Dieting

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CRR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal diet

Isocaloric ketogenic diet

Arm Description

no limitations on food consumption.

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

Outcomes

Primary Outcome Measures

Performance test under hypoxic conditions
VO2max cycling test on ergometer

Secondary Outcome Measures

Full Information

First Posted
October 26, 2022
Last Updated
October 31, 2022
Sponsor
Clinique Romande de Readaptation
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1. Study Identification

Unique Protocol Identification Number
NCT05603689
Brief Title
Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude
Acronym
ICKD
Official Title
Effect of a Four-week Isocaloric Ketogenic Diet on Physical Performance at Very High Altitude: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Romande de Readaptation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketogenic Dieting, Altitude Hypoxia, Physical Activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal diet
Arm Type
Active Comparator
Arm Description
no limitations on food consumption.
Arm Title
Isocaloric ketogenic diet
Arm Type
Experimental
Arm Description
We defined ICKD as a daily CHOs ingestion < 30 to 50 g.d-1, without any limitation in fat consumption.
Intervention Type
Dietary Supplement
Intervention Name(s)
Isocaloric ketogenic diet
Intervention Description
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 Outcome Measure Information:
Title
Performance test under hypoxic conditions
Description
VO2max cycling test on ergometer
Time Frame
after 4 weeks of diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Allet, PhD
Organizational Affiliation
HESso
Official's Role
Study Director
Facility Information:
Facility Name
CRR
City
Sion
ZIP/Postal Code
1951
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude

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