Muscle Protein SynthesisKBRNCT05679596
Exogenous Ketosis During Bed Rest in Older Adults
A study testing ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate in people with Muscle Protein Synthesis and Muscle Atrophy, run by McGill University at 1 site in Canada.
Trial summary
The goal of this randomized, double-blind, parallel group interventional study is to evaluate the effect of ketone bodies on healthy older adults (65-85 y) during 5 days of bed rest. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis, Muscle Atrophy, Insulin Sensitivity
- What is being tested?
- ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy, male, and female, older adults.
- Healthy will be defined as screen by the 2020 PAR-Q+, medical screening questionnaire, GAQ, and COVID-19 symptom questionnaire patient screening.
- 'Older' will be defined as being 65-85 years of age.
- Participants are required to not engage in structured resistance training for at least 6 months prior to participation in the study.
- Participants are willing to abide by the compliance rules of this study.
Who cannot join
- Pre-menopausal females: Women must be postmenopausal having not menstruated for at least 1 year prior to study participation. Hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism and may influence indices of muscle protein synthesis and breakdown (69-71).
- BMI <18.5 or > 30 kg ∙ m-2.
- Self-reported regular tobacco use and vaping products.
- Self-reported illicit drug use (e.g., growth hormone, testosterone, etc.)
- Individuals who have participated in studies within the past year involving a stable isotope of 2H.
- A history of thrombosis, diagnosed with type 2 diabetes mellitus by physician or HbA1c values of > 7.0%, dementia, coronary artery disease, musculoskeletal/orthopedic disorders, and severe allergies.
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- The use of medications known to modulate skeletal muscle metabolism (e.g., corticosteroids, hormone replacement therapy, non-steroidal anti-inflammatory drugs, metformin).
- The use of over-the-counter supplements (protein supplements, creatine, fish oil).
- Inability to adhere to any of the compliance rules judged by the principal investigator or medical doctor.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Institute - McGill University Health Centre
Montreal, Quebec, H4A 3J1
About this study
Official title: Ketone Bodies as Therapeutic Agents to Reduce the Harmful Effects of Bed Rest on Muscle Mass and Metabolic Health in Older Adults
The goal of this randomized, double-blind, parallel group interventional study is to evaluate the effect of ketone bodies on healthy older adults (65-85 y) during 5 days of bed rest. The main questions it aims to answer are:
Does supplementation of ketone bodies prevent the typical decline in muscle protein synthesis, muscle size, muscle function, insulin sensitivity, and muscle mitochondrial function that occurs in response to bed rest?
Read more
Researchers will compare ketone supplements (KET) to an energy matched control beverage (carbohydrates and fats) to see if the ketones can rescue the decline in muscle protein synthesis rates, muscle loss, muscle function, insulin sensitivity, and mitochondrial function due to 5 days of bed rest.
This may positively impact the heath of older adults subjected to bed rest.
Read the detailed description
Bed rest is a common feature of many clinical environments such as hospitals and long-term care facilities. However, physical inactivity due to bed rest decreases muscle size, muscle strength, and physical performance (i.e. rising from a chair) that can lead to a reduced quality of life and a higher risk of disease and death. Eating protein-rich foods and exercising normally helps to maintain muscle size by building proteins found in muscle. However, during bed rest there is a reduction in the rate at which proteins found in muscle are made and this leads to smaller muscles. Bed rest leads to problems with blood glucose regulation and insulin resistance which can increase the risk for diabetes. Both the loss of muscle size and insulin resistance are linked to problems with parts of our cells called mitochondria. Mitochondria do a lot of important things including keeping our cells full of energy. Bed rest occurs more frequently in older adults and also negatively impacts their health more than in younger adults. Sadly, there are limited options to prevent the problems associated with bed rest. Ketone bodies are molecules that come from fat that are normally produced in the body in response to reduced carbohydrate intake (i.e. a ketogenic diet). Recently ketone supplements have become available, which increase the amount of ketone bodies in the body without the need to limit carbohydrate intake from food. Elevated ketone bodies may help protect muscle size and health during bed rest by enhancing the process of building muscle proteins, improving blood glucose regulation, and helping mitochondria work optimally.
- Conditions
- Muscle Protein Synthesis, Muscle Atrophy, Insulin Sensitivity, Mitochondrial Function, Physical Inactivity, Cognitive Function
- Being tested
- ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate, carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)
- Keywords
- Bed rest, Muscle protein synthesis, Older adults, Muscle mitochondrial function, Insulin sensitivity, Ketone bodies
- Medical subject headings
- Muscular Atrophy, Insulin Resistance, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrateDietary supplement
Also called delta G Oxford Ketone Ester
Provided twice a day between meals.
carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)Dietary supplement
Provided twice a day between meals.
| Study group | Role | What they receive |
|---|---|---|
| Exogenous ketone monoester (KET) | Experimental | KET will be provided at a dose of 360 mg kg-1 body mass per serving at 2 servings per day between each main meal (ΔG®; TΔS Ltd, UK, Oxford, UK). Receives: Dietary Supplement: ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate |
| Energy matched control (CON) | Active comparator | CON will be provided at a dose energy matched to the KET supplement and consist of both carbohydrate (i.e., fructose) and fat (i.e., corn and canola oil 50:50 ratio). 1/3 of the supplemental energy will come from carbohydrate while 2/3 will come from fat. We have excluded protein from the CON supplement since it is well established to influence our primary outcome measure (MPS rates). A non-caloric sweetener will also be added to the CON supplement. Receives: Dietary Supplement: carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in integrated fractional synthesis rate (%/d) in response to bed rest with and without ketone monoester (KET) supplementation.
Integrative myofibrillar fractional synthesis rate will be calculated during baseline (day 0-5) and bed rest (day 5-10) phases.
Measured: Day 0-5 and day 5-10
Secondary outcomes (33)
Changes in whole body insulin sensitivity in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken in the fasted state before and after bed rest. Will measure blood glucose and insulin concentration during a hyperinsulinemic-euglycemic clamp.
Measured: Day-3 and Day 10.
Changes in whole-body lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation
Measurements taken in the fasted state using dual-energy x-ray absorptiometry (DXA) following urinary void before and after bed rest.
Measured: Day-3 and Day 10.
Changes in leg lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation
Measurements taken in the fasted state using dual-energy x-ray absorptiometry (DXA) following urinary void before and after bed rest.
Measured: Day -3 and Day 10.
Changes in quadriceps muscle volume in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken before and after bed rest via magnetic resonance imaging (MRI).
Measured: Day -3 and Day 10.
Changes in maximal voluntary isometric contraction (N/m) of the knee extensors in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken before and after bed rest using a Biodex dynamometer.
Measured: Day -3 and Day 10.
Changes in handgrip strength (kg) in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken before and after bed rest using a Jamar hand dynamometer.
Measured: Day -3 and Day 10.
Changes in physical performance (numerical score) as determined by short physical performance battery (SPPB) in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken before and after bed rest
Measured: Day -3 and Day 10.
Changes in physical performance (numerical score) as determined by 5-item physical performance test in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken before and after bed rest
Measured: Day -3 and Day 10.
Changes in cognitive status in response to bed rest with and without ketone monoester (KET) supplementation.
NIH Toolbox Cognition Battery (computerized). Measurements taken before and after bed rest
Measured: Day 4 and Day 9.
Changes in markers of inflammation in systemic circulation in response to bed rest with and without ketone monoester (KET) supplementation.
Markers of inflammation including: IL-1 beta, NF-K beta 1, IL-6, TNF-alpha, IFNY, MIP-1 beta will be evaluated. Measurements taken before, during, and after bed rest.
Measured: Day -3 and Day 10.
Changes in muscle mRNA expression of inflammatory regulators will be assessed in response to bed rest with and without ketone monoester (KET) supplementation.
Muscle mRNA expression of NFKB1, TLR-4,IL-6, TNF-alpha, and IL-1Beta will be evaluated. Measurements taken before and after bed rest
Measured: Day -3 and Day 10.
Changes in skeletal muscle phenotype in response to bed rest with and without ketone monoester (KET) supplementation.
Muscle cross-sections immunolabeled for type I, IIa, and IIx myosin heavy chains. Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Changes in skeletal muscle fiber size in response to bed rest with and without ketone monoester (KET) supplementation.
Muscle cross-sections analyzed for cross-sectional area.
Measured: Day -3 and Day 10.
Changes in mitochondrial content in response to bed rest with and without ketone monoester (KET) supplementation.
Via the assessment in succinate dehydrogenase activity.
Measured: Day -3 and Day 10.
Changes in mitochondrial respiration in response to bed rest with and without ketone monoester (KET) supplementation.
Assessed using standard substrate and inhibitor addition protocols in O2k high resolution Respirometer. Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Changes in mitochondrial calcium retention capacity (marker of mitochondrial propensity to trigger apoptosis) in response to bed rest with and without ketone monoester (KET) supplementation.
Determined spectrofluorometrically using the Calcium Green probe. Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Changes in mitochondrial reactive oxygen species (ROS) production in response to bed rest with and without ketone monoester (KET) supplementation.
Assessed using standard substrate and inhibitor addition protocols in O2k high resolution Respirometer. Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Changes in mitochondrial time to the permeability transition pore opening (marker of mitochondrial propensity to trigger apoptosis) in response to bed rest with and without ketone monoester (KET) supplementation.
Determined spectrofluorometrically using the Calcium Green probe. Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Changes in the phosphorylation status of anabolic signaling molecules modulating muscle protein synthesis (MPS) in response to bed rest with and without ketone monoester (KET) supplementation.
Western blotting - membranes will be probed with phospho-specific antibodies against IRS-1S527/Thr446, AktSer473, mTORSer2448, 4E-BP1Thr37/46, rpS6Ser240/244, p70S6KThr389. Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Changes in the phosphorylation status of catabolic signaling molecules modulating muscle protein breakdown (MPB) in response to bed rest with and without ketone monoester (KET) supplementation.
Western blotting - membranes will be probed with phospho-specific antibodies against FoxO3aThr32, MuRF1, and MAFbx. Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Blood beta-hydroxybutyrate concentrations (mmol/L) in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken at the start and end of bed rest.
Measured: Day 5 and Day 10
Changes in subjective pain via visual analog scale in response to bed rest with and without ketone monoester (KET) supplementation.
Throughout the 5 day bed rest period.
Measured: Day 5-10.
Changes in muscle area in response to bed rest with and without ketone monoester (KET) supplementation.
Peripheral quantitative computed tomography (pQCT). Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Changes in muscle density in response to bed rest with and without ketone monoester (KET) supplementation.
Peripheral quantitative computed tomography (pQCT). Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
2H enrichments in body water before and during bed rest with and without ketone monoester (KET) supplementation.
Throughout the baseline and bed rest period.
Measured: Day -1 to Day 10.
2H-alanine enrichment in venous blood before and during bed rest with and without ketone monoester (KET) supplementation.
Throughout the baseline and bed rest period.
Measured: Day -1 to Day 10.
Changes in resting metabolic rate (RMR) in response to bed rest with and without ketone monoester (KET) supplementation.
Measurements taken before and after bed rest.
Measured: Day -3 and Day 10.
Physical activity level via accelerometer before bed rest.
Throughout the baseline period
Measured: Day 0-4.
Changes in sleep disturbance (numerical score) during bed rest with and without ketone monoester (KET) supplementation.
Via Patient-Reported Outcomes Measurement Information System (PROMIS) Short form 8a. Measured throughout the 5 day bed rest period.
Measured: Day 5-10.
Changes in sleep quality (numerical score) during bed rest with and without ketone monoester (KET) supplementation.
Via Pittsburgh Sleep Quality Index (PSQI). Measured throughout the 5 day bed rest period.
Measured: Day 5-10.
Average habitual dietary intake assessed using Keenoa for 3 days (a food tracker application).
Dietary intake will be assessed for total energy (kcals) and macronutrient (protein, carbohydrate, and fat consumption; g) intake.
Measured: Measured before bed rest.
Changes in Thigh Absolute Synthetic Rate (ASR) in response to bed rest with and without ketone monoester (KET) supplementation.
Changes in Thigh Absolute Synthetic Rate (ASR) will be calculated during baseline (day 0-5) and bed rest (day 5-10) phases.
Measured: Day 0-5 and day 5-10
Changes in Thigh Absolute Protein Breakdown Rate (ABR) in response to bed rest with and without ketone monoester (KET) supplementation.
Changes in Thigh Absolute Protein Breakdown Rate (ABR) will be calculated during baseline (day 0-5) and bed rest (day 5-10) phases.
Measured: Day 0-5 and day 5-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start27 Feb 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, parallel group study design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Tyler Churchward-Venne, McGill University
- Investigators
- Tyler A Churchward-Venne, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679596
- Sponsor's protocol ID
- 427929
- Acronym
- KBR
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Bodies as Therapeutic Agents to Reduce the Harmful Effects of Bed Rest on Muscle Mass and Metabolic Health in Older Adults
- ClinicalTrials.gov ID
- NCT05679596
- Acronym / sponsor ID
- KBR / 427929
- Conditions
- Muscle Protein Synthesis, Muscle Atrophy, Insulin Sensitivity, Mitochondrial Function, Physical Inactivity, Cognitive Function
- Keywords
- Bed rest, Muscle protein synthesis, Older adults, Muscle mitochondrial function, Insulin sensitivity, Ketone bodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, double-blind, parallel group interventional study is to evaluate the effect of ketone bodies on healthy older adults (65-85 y) during 5 days of bed rest. The main questions it aims to answer are:
Does supplementation of ketone bodies prevent the typical decline in muscle protein synthesis, muscle size, muscle function, insulin sensitivity, and muscle mitochondrial function that occurs in response to bed rest?
Researchers will compare ketone supplements (KET) to an energy matched control beverage (carbohydrates and fats) to see if the ketones can rescue the decline in muscle protein synthesis rates, muscle loss, muscle function, insulin sensitivity, and mitochondrial function due to 5 days of bed rest.
This may positively impact the heath of older adults subjected to bed rest.
Detailed description
Bed rest is a common feature of many clinical environments such as hospitals and long-term care facilities. However, physical inactivity due to bed rest decreases muscle size, muscle strength, and physical performance (i.e. rising from a chair) that can lead to a reduced quality of life and a higher risk of disease and death. Eating protein-rich foods and exercising normally helps to maintain muscle size by building proteins found in muscle. However, during bed rest there is a reduction in the rate at which proteins found in muscle are made and this leads to smaller muscles. Bed rest leads to problems with blood glucose regulation and insulin resistance which can increase the risk for diabetes. Both the loss of muscle size and insulin resistance are linked to problems with parts of our cells called mitochondria. Mitochondria do a lot of important things including keeping our cells full of energy. Bed rest occurs more frequently in older adults and also negatively impacts their health more than in younger adults. Sadly, there are limited options to prevent the problems associated with bed rest. Ketone bodies are molecules that come from fat that are normally produced in the body in response to reduced carbohydrate intake (i.e. a ketogenic diet). Recently ketone supplements have become available, which increase the amount of ketone bodies in the body without the need to limit carbohydrate intake from food. Elevated ketone bodies may help protect muscle size and health during bed rest by enhancing the process of building muscle proteins, improving blood glucose regulation, and helping mitochondria work optimally.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, parallel group study design.
| Arm | Type | Receives |
|---|---|---|
| Exogenous ketone monoester (KET) | Experimental | Dietary Supplement: ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrateKET will be provided at a dose of 360 mg kg-1 body mass per serving at 2 servings per day between each main meal (ΔG®; TΔS Ltd, UK, Oxford, UK). |
| Energy matched control (CON) | Active comparator | Dietary Supplement: carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)CON will be provided at a dose energy matched to the KET supplement and consist of both carbohydrate (i.e., fructose) and fat (i.e., corn and canola oil 50:50 ratio). 1/3 of the supplemental energy will come from carbohydrate while 2/3 will come from fat. We have excluded protein from the CON supplement since it is well established to influence our primary outcome measure (MPS rates). A non-caloric sweetener will also be added to the CON supplement. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Healthy, male, and female, older adults.
- Healthy will be defined as screen by the 2020 PAR-Q+, medical screening questionnaire, GAQ, and COVID-19 symptom questionnaire patient screening.
- 'Older' will be defined as being 65-85 years of age.
- Participants are required to not engage in structured resistance training for at least 6 months prior to participation in the study.
- Participants are willing to abide by the compliance rules of this study.
Key exclusion criteria (9 listed)
- Pre-menopausal females: Women must be postmenopausal having not menstruated for at least 1 year prior to study participation. Hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism and may influence indices of muscle protein synthesis and breakdown (69-71).
- BMI <18.5 or > 30 kg ∙ m-2.
- Self-reported regular tobacco use and vaping products.
- Self-reported illicit drug use (e.g., growth hormone, testosterone, etc.)
- Individuals who have participated in studies within the past year involving a stable isotope of 2H.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrateAlso: delta G Oxford Ketone EsterProvided twice a day between meals. | Dietary supplement | Exogenous ketone monoester (KET) |
| carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)Provided twice a day between meals. | Dietary supplement | Energy matched control (CON) |
Primary outcome
Changes in integrated fractional synthesis rate (%/d) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 0-5 and day 5-10
Integrative myofibrillar fractional synthesis rate will be calculated during baseline (day 0-5) and bed rest (day 5-10) phases.
33 secondary outcomes
Changes in whole body insulin sensitivity in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day-3 and Day 10.
Changes in whole-body lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation
Time frame: Day-3 and Day 10.
Changes in leg lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation
Time frame: Day -3 and Day 10.
Changes in quadriceps muscle volume in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in maximal voluntary isometric contraction (N/m) of the knee extensors in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in handgrip strength (kg) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in physical performance (numerical score) as determined by short physical performance battery (SPPB) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in physical performance (numerical score) as determined by 5-item physical performance test in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in cognitive status in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 4 and Day 9.
Changes in markers of inflammation in systemic circulation in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in muscle mRNA expression of inflammatory regulators will be assessed in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in skeletal muscle phenotype in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in skeletal muscle fiber size in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in mitochondrial content in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in mitochondrial respiration in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in mitochondrial calcium retention capacity (marker of mitochondrial propensity to trigger apoptosis) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in mitochondrial reactive oxygen species (ROS) production in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in mitochondrial time to the permeability transition pore opening (marker of mitochondrial propensity to trigger apoptosis) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in the phosphorylation status of anabolic signaling molecules modulating muscle protein synthesis (MPS) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in the phosphorylation status of catabolic signaling molecules modulating muscle protein breakdown (MPB) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Blood beta-hydroxybutyrate concentrations (mmol/L) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 5 and Day 10
Changes in subjective pain via visual analog scale in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 5-10.
Changes in muscle area in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Changes in muscle density in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
2H enrichments in body water before and during bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -1 to Day 10.
2H-alanine enrichment in venous blood before and during bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -1 to Day 10.
Changes in resting metabolic rate (RMR) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day -3 and Day 10.
Physical activity level via accelerometer before bed rest.
Time frame: Day 0-4.
Changes in sleep disturbance (numerical score) during bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 5-10.
Changes in sleep quality (numerical score) during bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 5-10.
Average habitual dietary intake assessed using Keenoa for 3 days (a food tracker application).
Time frame: Measured before bed rest.
Changes in Thigh Absolute Synthetic Rate (ASR) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 0-5 and day 5-10
Changes in Thigh Absolute Protein Breakdown Rate (ABR) in response to bed rest with and without ketone monoester (KET) supplementation.
Time frame: Day 0-5 and day 5-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler A Churchward-Venne, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate in people with Muscle Protein Synthesis and Muscle Atrophy, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in integrated fractional synthesis rate (%/d) in response to bed rest with and without ketone monoester (KET) supplementation. (time frame: Day 0-5 and day 5-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.