Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Type 2 Diabetes Clinical Trial

Official title: Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With the Metabolic Phenotype of Heart Failure With Preserved Ejection Fraction

Status Recruiting

Clinical Trial Summary

This study is being done to evaluate how a ketone ester (KE) beverage affects heart function and health in people with heart failure compared to a placebo beverage (a beverage made with standard food ingredients that do not contain ketone esters).

Clinical Trial Description

This study is a single center, randomized controlled study of up to 30 subjects with metabolic heart failure with preserved ejection fraction (HFpEF) phenotype. The study is designed to compare the effects of KE versus an energy and volume matched placebo on maximal exercise performance measured by CPET. Eligible subjects will have a known diagnosis of HF or type 2 diabetes or metabolic syndrome or obesity and will be selected from a larger population being followed in the Heart Failure Clinic at the Ohio State University Wexner Medical Center. Enrolled subjects will be stratified by sex to ensure equal proportions of men and women in each group (KE and placebo) and then randomly assigned (1:1) to a group, before washing out and crossing over to the other group (KE or Placebo). Subjects will follow the intervention of twice daily consumption of the KE or placebo for a period of 6 weeks, followed by a 4 week washout. All subjects will then crossover to the other group (KE or placebo) for another 6 weeks of intervention. Primary data will be collected at baseline and at the end of the 6-week intervention for both groups. In addition, subjects will undergo daily monitoring of blood markers, blood pressure, heart rate, and overall health. All subjects will continue standard HF and diabetes therapies with adjustment in medications as needed.

Cardiopulmonary exercise testing (CPET) also known as Maximal oxygen consumption testing (VO2) will be used to assess exercise performance, and Cardiac Magnetic Resonance Imaging (CMR) to evaluate cardiac function, myocardial blood flow, and cardiac and vascular function. CMR will provide insightful data on the magnitude, timeline, and functional impact of nutritional ketosis on cardiovascular function in patients diagnosed with HFpEF. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Metabolic Syndrome
• Type 2 Diabetes

• NCT number: NCT06078683
• Study type: Interventional
• Source: Ohio State University
• Contact: Debbie Scandling, BS
• Phone: 614-688-5623
• Email: debbie.scandling@osumc.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Completion date: August 31, 2026