Ketone Administration During Inactivity and Retraining

Study Overview
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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.

Official Title
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Effect of Oral Ketone Administration During Inactivity-induced Muscle Atrophy and Retraining-induced Regeneration

Conditions
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Exercise, Healthy Male/Female Subjects

Intervention / Treatment
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* Dietary Supplement: Ketone ester
* Dietary Supplement: Medium Chain Triglyceride (MCT) oil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Ketone placebo will be provided | Dietary Supplement: Medium Chain Triglyceride (MCT) oil<br>* A daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period<br>|
| Experimental: Ketone<br>Ketone esters will be provided | Dietary Supplement: Ketone ester<br>* A daily dose of 3x20g of ketone ester supplementation during a six week intervention period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise performance | Changes in exercise performance as evaluated during a graded exercise test | Day 0 - day 14 - day 28 - day 42 | 
| Echo-Doppler measurement of femoral artery | Change in blood flow of arteria femoralis | Day 0 - Day 14 - Day 28 - Day 42 | 
| Muscle volume | Change in volume of quadriceps evaluated by computed-tomography scan | Day 0 - Day 14 - Day 28 - Day 42 | 
| Muscular functional capacity | Change in mean power produced during 30 unilateral knee extensions on a knee-extension apparatus | Day 0 - Day 14 - Day 28 - Day 42 | 
| Skeletal muscle biopsies | Changes in myofibrillar protein synthesis | Day 0 - Day 14 - Day 28 - Day 42 | 
| Skeletal muscle biopsies | Changes in connective tissue protein synthesis | Day 0 - Day 14 - Day 28 - Day 42 | 
| Blood marker of collagen synthesis | Change in PINP (n-terminal peptide of pro-collagen I) concentration in blood | Day 0 - Day 14 - Day 28 - Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketone, Inactivity-induced muscle atrophy, Retraining-induced regeneration