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

NCT05348460 | Completed

• 1 other identifier: 201900710
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction; Heart Failure

Keywords

Heart Failure; Ketone Body; HFrEF; Skeletal Muscle Metabolism; Mitochondrial Ketone Oxidation; 31P MRS; Pi/Pcr

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate and magnitude of change in PCr and Pi concentrations during recovery

  During study visit

• Intramuscular pH

  During study visit

• Maximal exercise performance

  During study visit

• 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

Study Arms (2)

Ketone - Placebo treatment

OTHER

Patients will first receive a supplemental drink containing a ketone ester before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the placebo treatment.

Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight); Dietary Supplement: Taste-matched, isovolumic placebo drink

Placebo - Ketone treatment

OTHER

Patients will first receive a placebodrink before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the supplemental drink containing a ketone ester.

Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight); Dietary Supplement: Taste-matched, isovolumic placebo drink

Interventions

Ketone ester drink (DeltaG®, 500 mg/kg body weight) DIETARY_SUPPLEMENT

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.

Ketone - Placebo treatment; Placebo - Ketone treatment

Taste-matched, isovolumic placebo drink DIETARY_SUPPLEMENT

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.

Ketone - Placebo treatment; Placebo - Ketone treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Heart Failure NYHA II - III
• LVEF ≤40%
• Stable for the last 1 month prior to the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Netherlands Heart Foundation: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Daan Westenbrink, MD PhD

  Unversity Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind masking
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled cross-over design

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 27, 2022
• Study Start: February 15, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

NL (1)