NCT05679596: KBR

Exogenous Ketosis During Bed Rest in Older Adults

Completed NA Last updated 7 February 2024

What this trial tests

NA trial testing ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate in Muscle Protein Synthesis in 30 participants. Completed in 15 November 2023.

Timeline

27 February 2023

Primary endpoint
15 November 2023

15 November 2023

Quick facts

Lead sponsor	McGill University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	30
Start date	27 February 2023
Primary completion	15 November 2023
Estimated completion	15 November 2023
Sites	1 location across Canada

Drugs / interventions tested

• ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate
• carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)

Conditions studied

• Muscle Protein Synthesis — all drugs for Muscle Protein Synthesis →
• Muscle Atrophy — all drugs for Muscle Atrophy →
• Insulin Sensitivity — all drugs for Insulin Sensitivity →
• Mitochondrial Function — all drugs for Mitochondrial Function →

Sponsor

McGill University

Who can join

Adults 65 to 85, any sex, with Muscle Protein Synthesis or Muscle Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Unraveling the Translational Relevance of β-Hydroxybutyrate as an Intermediate Metabolite and Signaling Molecule.
   Pali DV, Kim S, Mantik KEK, Lee JB, et al · · 2025 · cited 4× · PMID 40806491 · DOI 10.3390/ijms26157362