The Metabolic Effects of β-hydroxybutyrate on Working Skeletal Muscle

NCT05732909 | Completed

• 1 other identifier: ketomr
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test ketone bodies in healthy elderly and young individuals. The main question it aims to answer are:

• 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.

Conditions

Ketonemia; Muscle Disorder; Aging; Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

• Work efficiency

  External work performed by the ankle during dorsiflexion per ATP consumed. ATP consumption is assessed by 31P-MRS while external force is measured by the dynamometer.

  Over 60 minutes on each of the two experimental days.

Secondary Outcomes (21)

• Oxidative capacity

  Over 20 minutes at each of the two experimental days.

• Glucose oxidation rates (only young group)

  At 10 minute intervals over the last 30 min of the 90 min fixed intensity cycling on each experimental day.

• Palmitate flux (only young group)

  At 10 minute intervals over the last 30 min of the 90 min fixed intensity cycling on each experimental day.

• ATP generation

  Over 30 minutes at each of the two experimental days.

• Mitochondrial function

  Just before and immediately after the constant load cycling at each of the two experimental days.

Other Outcomes (4)

• Blood haemoglobin

  Measured at the beginning and the end of each experimental day

• Blood Sodium

  Measured at the beginning and the end of each experimental day

• Blood potassium

  Measured at the beginning and the end of each experimental day

Study Arms (2)

First Ketone, then placebo

EXPERIMENTAL

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.

Dietary Supplement: D-β-hydroxybutyrate/D 1,3 butanediol monoester

First placebo, then ketone

EXPERIMENTAL

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.

Dietary Supplement: D-β-hydroxybutyrate/D 1,3 butanediol monoester

Interventions

D-β-hydroxybutyrate/D 1,3 butanediol monoester DIETARY_SUPPLEMENT

Ketone monoester

First Ketone, then placebo; First placebo, then ketone

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male 20-25 years old (n = 12) OR male 65-85 years old (n = 12)
• BMI range: 19 to 27
• Stable weight (\< 5% change over last 6 months)
• Less than 3 x 60 min of structured exercise per week.

You may not qualify if:

• Medication that affect energy metabolism.
• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Diabetes Academy: collaborator
• AP Moeller Foundation: collaborator
• Aarhus University Hospital: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Andersen OE, Larsen RG, Moller N, Stouge A, Ringgaard S, Overgaard K, Jessen N. Ketone Monoester Increases Skeletal Muscle Power and Energy Turnover in Older but Not Young Men Without Affecting Metabolic Economy: A Controlled, Double Blind, Cross-Over Trial. Acta Physiol (Oxf). 2026 Mar;242(3):e70161. doi: 10.1111/apha.70161.

  PMID: 41644499 DERIVED

MeSH Terms

Conditions

Metabolic Diseases; Ketosis; Muscular Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Acidosis; Acid-Base Imbalance; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Niels Jessen, Professor

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-day cross-over design.

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 17, 2023
• Study Start: December 22, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: March 6, 2026

Record last verified: 2023-01

Locations

DK (1)