Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure

Heart Failure Clinical Trial

— KETONE-HF  

Official title:

Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348460
• Other study ID #: 201900710
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.

Description:

The goal of this study is to investigate if oral ketone supplementation stimulates mitochondrial ATP production and improves exercise performance in patients with chronic HF. In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. Endpoints include rate and magnitude of change in phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise, rate and magnitude of change in PCr and Pi concentrations during recovery, rates and magnitude of change in intramuscular pH during exercise and recovery, maximal exercise performance and change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic Heart Failure NYHA II - III

• LVEF =40%

• Stable for the last 1 month prior to the study

Exclusion Criteria:

• Age <18 years;

• Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);

• Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;

• Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb =6 mmol/L);

• Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);

• Absolute contra-indications to undergo MRI according to the current UMCG protocols and guidelines (e.g. non-conditional medical device, recent device implantation, incompatible ferromagnetic objects in the body).

• BMI < 16 kg/m2; BMI > 35 kg/m2

• Unable to understand study procedures;

• Unable or unwilling to provide informed consent.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Dietary Supplement:
• Ketone ester drink (DeltaG®, 500 mg/kg body weight)
In a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
• Taste-matched, isovolumic placebo drink
In a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Netherlands Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise	Rate and magnitude of change in PCr and Pi concentrations from baseline to maximum exercise.	During study-visit
Secondary	Rate and magnitude of change in PCr and Pi concentrations during recovery	Rate and magnitude of change in PCr and Pi concentrations during recovery of change in PCr and Pi is expressed as change in Pi/PCr (?Pi/PCr)	During study visit
Secondary	Intramuscular pH	Rates and magnitude of change in intramuscular pH during exercise and recovery	During study visit
Secondary	Maximal exercise performance	Maximal exercise performance	During study visit
Secondary	Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise	Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise	During study visit