Research Institute - McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
NCT Number: NCT05679596
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.
Looking for future studies?
Notify Me65 year–85 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H4A 3J1, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Provided twice a day between meals.
Other names: delta G Oxford Ketone Ester
Provided twice a day between meals.
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.
Time frame: Day-3 and Day 10.
Measurements taken in the fasted state before and after bed rest. Will measure blood glucose and insulin concentration during a hyperinsulinemic-euglycemic clamp.
Time frame: Day-3 and Day 10.
Measurements taken in the fasted state using dual-energy x-ray absorptiometry (DXA) following urinary void before and after bed rest.
Time frame: Day -3 and Day 10.
Measurements taken in the fasted state using dual-energy x-ray absorptiometry (DXA) following urinary void before and after bed rest.
Time frame: Day -3 and Day 10.
Measurements taken before and after bed rest via magnetic resonance imaging (MRI).
Time frame: Day -3 and Day 10.
Measurements taken before and after bed rest using a Biodex dynamometer.
Time frame: Day -3 and Day 10.
Measurements taken before and after bed rest using a Jamar hand dynamometer.
Time frame: Day -3 and Day 10.
Measurements taken before and after bed rest
Time frame: Day -3 and Day 10.
Measurements taken before and after bed rest
Time frame: Day 4 and Day 9.
NIH Toolbox Cognition Battery (computerized). Measurements taken before and after bed rest
Time frame: Day -3 and Day 10.
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.
Time frame: Day -3 and Day 10.
Muscle mRNA expression of NFKB1, TLR-4,IL-6, TNF-alpha, and IL-1Beta will be evaluated. Measurements taken before and after bed rest
Time frame: Day -3 and Day 10.
Muscle cross-sections immunolabeled for type I, IIa, and IIx myosin heavy chains. Measurements taken before and after bed rest.
Time frame: Day -3 and Day 10.
Muscle cross-sections analyzed for cross-sectional area.
Time frame: Day -3 and Day 10.
Via the assessment in succinate dehydrogenase activity.
Time frame: Day -3 and Day 10.
Assessed using standard substrate and inhibitor addition protocols in O2k high resolution Respirometer. Measurements taken before and after bed rest.
Time frame: Day -3 and Day 10.
Determined spectrofluorometrically using the Calcium Green probe. Measurements taken before and after bed rest.
Time frame: Day -3 and Day 10.
Assessed using standard substrate and inhibitor addition protocols in O2k high resolution Respirometer. Measurements taken before and after bed rest.
Time frame: Day -3 and Day 10.
Determined spectrofluorometrically using the Calcium Green probe. Measurements taken before and after bed rest.
Time frame: Day -3 and Day 10.
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.
Time frame: Day -3 and Day 10.
Western blotting - membranes will be probed with phospho-specific antibodies against FoxO3aThr32, MuRF1, and MAFbx. Measurements taken before and after bed rest.
Time frame: Day 5 and Day 10
Measurements taken at the start and end of bed rest.
Time frame: Day 5-10.
Throughout the 5 day bed rest period.
Time frame: Day -3 and Day 10.
Peripheral quantitative computed tomography (pQCT). Measurements taken before and after bed rest.
Time frame: Day -3 and Day 10.
Peripheral quantitative computed tomography (pQCT). Measurements taken before and after bed rest.
Time frame: Day -1 to Day 10.
Throughout the baseline and bed rest period.
Time frame: Day -1 to Day 10.
Throughout the baseline and bed rest period.
Time frame: Day -3 and Day 10.
Measurements taken before and after bed rest.
Time frame: Day 0-4.
Throughout the baseline period
Time frame: Day 5-10.
Via Patient-Reported Outcomes Measurement Information System (PROMIS) Short form 8a. Measured throughout the 5 day bed rest period.
Time frame: Day 5-10.
Via Pittsburgh Sleep Quality Index (PSQI). Measured throughout the 5 day bed rest period.
Time frame: Measured before bed rest.
Dietary intake will be assessed for total energy (kcals) and macronutrient (protein, carbohydrate, and fat consumption; g) intake.
Time frame: Day 0-5 and day 5-10
Changes in Thigh Absolute Synthetic Rate (ASR) will be calculated during baseline (day 0-5) and bed rest (day 5-10) phases.
Time frame: Day 0-5 and day 5-10
Changes in Thigh Absolute Protein Breakdown Rate (ABR) will be calculated during baseline (day 0-5) and bed rest (day 5-10) phases.
McGill University
Other
Ketone Bodies as Therapeutic Agents to Reduce the Harmful Effects of Bed Rest on Muscle Mass and Metabolic Health in Older Adults
Acronym: KBR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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