The Metabolic Effects of β-hydroxybutyrate on Working Skeletal Muscle
NCT ID: NCT05732909
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
25 participants
INTERVENTIONAL
2022-12-22
2024-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• Do ketone bodies improve skeletal muscle function?
Participants will ingest a ketone monoester and skeletal muscle function will then be evaluated by:
* Special magnetic imaging techniques
* Intravenous infusion of tracer-marked nutrients
* Performance tests on a ergometer bike and in a dynamometer
Researchers will compare the outcomes between within the young and elderly groups and between the young and the elderly group to investigate if age has an effect on the outcomes.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OBJECTIVE The study aims to investigate the effects of beta-hydroxybutyrate ingested as a monoester on skeletal muscle function and metabolism during muscle work in young and elderly individuals.
DESIGN Healthy young (20-25 years) and elderly (65-85 years) untrained males will be paired based on age corrected VO2-max. Participants will be evaluated in a double blinded cross-over design on two study days: One day with ketone ester ingestion (D-beta-hydroxybutyrate/D-1,3-butanediol; KetoneAid Pro KE4), one day with ingestion of a volume and calorie and taste matched placebo (lipid emulsion). Blood ketone levels will be kept elevated through a sipping protocol. During both conditions a low glucose dose will be continuously infused to block physiological ketogenesis.
The order of the study days will be randomized and interspaced by at least 4 weeks.
On experimental days, participants meet fasted to perform voluntary contractions with tibialis anterior muscles in a MR compatible dynamometer while oxidative capacity, ATP generation, intramuscular pH, fatiguability and work efficiency is evaluated through 31P-MR spectroscopy.
After, participants will bike at a fixed intensity (\~45% of Wmax) while lipid fluxes and glucose oxidation rates are measured by palmitate- and glucose tracer infusions and carbamide-corrected indirect calorimetry over 60 min. This was initially intended for both young and elderly individuals, but only involves the young group, as the elderly group had difficulties completing 60 min cycling.
Lastly on the study days, participants will perform a cycling test as a measure of performance starting at 70 % of Wmax for 5 min thereafter increasing by 10 % of Wmax every 1 min until exhaustion. Muscle biopsies are obtained before (both groups) and just following fixed intensity cycle work (only young group). Adipose tissue biopsies are collected at the beginning of the experimental day (both groups) before ketone/placebo ingestion and after the constant load cycle work (only young group). Blood samples are performed throughout the day to assess substrate levels, hormones and for proteomics analysis.
Before each study day, participant's activity level is measured for 7 days by accelerometry (ActiGraph). Participants will log their diet 3 days prior to each experimental day. Participants are asked to ingest a similar diet 2 days before both experimental days and to withstand from strenuous exercise 2 days prior to both experimental days. Participants are asked not to make any significant changes to their lifestyle while taking part in the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
First Ketone, then placebo
Ingestion of ketone monoester D-β-hydroxybutyrate / D 1,3 butanediol monoester on first experimental day and ingestion of a fat placebo drink on the second experimental day.
D-β-hydroxybutyrate/D 1,3 butanediol monoester
Ketone monoester
First placebo, then ketone
Ingestion of a fat placebo drink on the first experimental day followed by ingestion of ketone monoester D-β-hydroxybutyrate / D 1,3 butanediol monoester on the second experimental day.
D-β-hydroxybutyrate/D 1,3 butanediol monoester
Ketone monoester
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
D-β-hydroxybutyrate/D 1,3 butanediol monoester
Ketone monoester
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI range: 19 to 27
* Stable weight (\< 5% change over last 6 months)
* Less than 3 x 60 min of structured exercise per week.
Exclusion Criteria
* Non-MR-compatible metals or electric devices in the body.
* Anaemia or bleeding disorders.
* Heart, lung or other disease that affects the subjects ability to exercise.
* Smoking.
* Drug abuse.
* Lack of compliance.
* Known allergy towards local anaesthetics.
* Any condition that the principal investigator considers unsuitable for the subject's ability to complete the study.
20 Years
85 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Danish Diabetes Academy
OTHER
AP Moeller Foundation
OTHER
Aarhus University Hospital
OTHER
Novo Nordisk A/S
INDUSTRY
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Niels Jessen, Professor
Role: STUDY_DIRECTOR
Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Steno Diabetes Center Aarhus
Aarhus, Aarhus N, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ketomr
Identifier Type: -
Identifier Source: org_study_id