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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

Quick Stats
Studies 40
Trials 100
Completed PHASE2 INTERVENTIONAL NCT04633460

Acute Effects of Exogenous Ketone Ester Administration in Heart Failure

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to test whether a ketone ester drink will improve exercise in people with heart failure (HF) compared to a placebo. In HF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. There may be several reasons why these symptoms occur. There is some evidence that in addition to problems with the heart, patients with HF also have problems with their arteries and muscles that affect their ability to exercise. Ketones have been shown to improve exercise capacity in healthy volunteers, which may be related to effects on the heart function or on muscles. An infusion of ketones through an intravenous (IV) line has also been shown to significantly improve heart function, but whether a drink can produce similar improvements in HF patients is not known. This drink has been given status by Food and Drug Administration as "generally regarded as safe". The use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.

Detailed Description

This is a randomized, crossover trial of ketone ester versus placebo in 20 patients with heart failure with preserved ejection fraction. Participants come for a baseline assessment. If they meet eligibility criteria, they are randomized to receive ketone ester first or placebo first. After approximately a week washout period, participants return for the last visit to receive the product they did not receive at the previous visit.

Interventions

Name: Ketone ester
Type: DIETARY_SUPPLEMENT
Description: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis
Name: placebo drink
Type: DIETARY_SUPPLEMENT
Description: KE free placebo drink

Primary Outcomes

Measure: Maximal Exercise Capacity (Peak VO2) Assessed by Cardiopulmonary Exercise Testing
TimeFrame: Assessed 60 minutes after the intervention.
Description: Peak VO2
Measure: Submaximal Exercise Capacity (Exercise Time at 75% of Peak Workload) Assessed by Cardiopulmonary Exercise Testing.
TimeFrame: Assessed 30 minutes after the intervention.
Description: Exercise time at 75% of peak workload

Trial Information

NCT ID

NCT04633460

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

University of Pennsylvania

Last Updated

December 15, 2025