Acute Oral Ketones or Carbohydrate Supplement Modify Heart Function in Heart Failure?

NCT ID: NCT05651529

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-16
• Study Completion Date: 2025-12-16

Brief Summary

Does oral intake of exogenous ketone salt improve heart function measured by cardiac MRI in heart failure compared to oral intake of a carbohydrate placebo?

Detailed Description

This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt in heart failure condition.

Participants will have 2 different cardiac MRI to perform:

1. Fasting with exogenous ketone salt supplement

2. Fasting with exogenous carbohydrate supplement

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Ketone

Group Type: ACTIVE_COMPARATOR

exogenous ketone salt supplement

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Fasting water and with exogenous ketone salt supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.

Placebo

Group Type: PLACEBO_COMPARATOR

exogenous carbohydrate supplement

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Fasting water and with exogenous carbohydrate supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.

Interventions

exogenous ketone salt supplement

Dietary Supplement: Fasting water and with exogenous ketone salt supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.

Intervention Type: DIETARY_SUPPLEMENT

exogenous carbohydrate supplement

Dietary Supplement: Fasting water and with exogenous carbohydrate supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Post-Prandial with exogenous ketone salt supplement; Post-Prandial with exogenous carbohydrate supplement

Eligibility Criteria

Inclusion Criteria

• Patients with heart failure with left ventricle ejection fraction of 40%
• Heart failure of ischemic or dilated etiology
• Ambulatory patient with a NYHA functional class of II-III;
• Stable symptoms and no change in medical therapy in the last month.

Exclusion Criteria

• Diabetes
• Patients treated with any SGLT2i;
• Chronic kidney disease
• Acute coronary syndrome in the last 3 months;
• Use of parenteral inotropic agents;
• Persistent or permanent atrial fibrillation or atrial flutter;
• Presence of pacemaker or defibrillator;
• Medical condition that causes malabsorption of the test material;
• Under ketogenic diet, or using exogenous ketone supplements
• Use of nicotinamide adenine dinucleotide (NAD) precursor supplements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nestlé Health Science

INDUSTRY

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie

Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke, departement de médecine

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

2023-4720

Identifier Type: -

Identifier Source: org_study_id