Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure (KINETICS2)

University of Aarhus

Status and phase: Enrolling; Phase 2

Conditions: Ketosis; Heart Failure

Treatments: Dietary Supplement: KetoneAid KE4 Pro Monoester; Dietary Supplement: Science in Sport Go Enegy

Study type: Interventional

Funder types: Other

Identifiers

NCT04594265

KETO-KINETICS 2 1-10-72-23-20

Details and patient eligibility

About

We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40%

Exclusion Criteria: Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 3 patient groups, including a placebo group

Ketone Monoester

Experimental group

Description:

Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)

Treatment:

Dietary Supplement: KetoneAid KE4 Pro Monoester

Placebo Treatment

Placebo Comparator group

Description:

Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.

Treatment:

Dietary Supplement: Science in Sport Go Enegy

Ketone Monoester in presence of low-dose insulin clamp

Active Comparator group

Description:

Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism

Treatment:

Dietary Supplement: KetoneAid KE4 Pro Monoester