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Ketone Administration During Inactivity and Retraining

NCT ID: NCT05398042

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-08-31

Brief Summary

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The aim of this study is to investigate the effect of oral ketone administration during inactivity-induced muscle atrophy and retraining-induced regeneration. Potential changes in muscle function (cycling performance, knee-extension force and power, jump height) and mass, blood flow and the muscular extracellular matrix will be the main focus. In this context, the dominant leg of the participants (n=24) will be immobilized with a brace for 2 weeks and subsequently retrained in a 4-week progressive resistance exercise training program to stimulate muscle regeneration. During the immobilization and rehabilitation period, participants receive either ketone ester (KE) or placebo (CON). 4 experimental sessions are performed during this time frame in order to evaluate the effects of the trial.

Detailed Description

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Conditions

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Exercise Healthy Male/Female Subjects

Keywords

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Ketone Inactivity-induced muscle atrophy Retraining-induced regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Ketone placebo will be provided

Group Type PLACEBO_COMPARATOR

Medium Chain Triglyceride (MCT) oil

Intervention Type DIETARY_SUPPLEMENT

A daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period

Ketone

Ketone esters will be provided

Group Type EXPERIMENTAL

Ketone ester

Intervention Type DIETARY_SUPPLEMENT

A daily dose of 3x20g of ketone ester supplementation during a six week intervention period

Interventions

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Ketone ester

A daily dose of 3x20g of ketone ester supplementation during a six week intervention period

Intervention Type DIETARY_SUPPLEMENT

Medium Chain Triglyceride (MCT) oil

A daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Recreational sports participation, including general fitness training, between 2 and 5 hours max per week
* Good health status confirmed by a medical screening
* Body mass index between 18 and 25

Exclusion Criteria

* Any kind of injury/pathology that is a contra-indication to perform resistance exercise
* Intake of any medication or nutritional supplement that could impact muscle protein synthesis during the period of the study
* Intake of any whey protein, casein or branched-chain amino acid supplement or anti-inflammatory drug from 1 month prior to the start of the study
* Blood donation within 3 months prior to the start of the study
* Smoking
* Pregnant
* More than 3 alcoholic beverages per day
* Current participation in another research trial
* Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
* Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)
* (Cow's) milk protein allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Peter Hespel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Exercise Physiology Research Group

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Peter Hespel, Prof.

Role: CONTACT

Phone: +3216329091

Email: [email protected]

Ruben Robberechts

Role: CONTACT

Phone: +3272833757

Email: [email protected]

Facility Contacts

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Peter Hespel, Prof.

Role: primary

Other Identifiers

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S65695

Identifier Type: -

Identifier Source: org_study_id