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

NCT ID: NCT05651529

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2024-12-16

Brief Summary

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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

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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

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Heart Failure

Keywords

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Ketones Heart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Triple (Participant, Investigator, Outcomes Assessor) Investigators, participants and outcome assessors will be fully blinded.

Interventions

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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

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

Eligibility Criteria

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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

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Nestlé Health Science Spain

INDUSTRY

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie

Sherbrooke, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Sherbrooke, departement de médecine

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2023-4720

Identifier Type: -

Identifier Source: org_study_id