NCT04921293

Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial will evaluate the effect of a ketogenic diet and/or exogenous administration of ketone bodies vs conventional diet on the ejection fraction of patients with non-ischemic chronic heart failure, measuring MRI biomarkers.

Detailed description

Evidence in both animals and humans suggests ketosis could be beneficial for people living with chronic heart failure. To date, no study has compared endogenous vs exogenous ketosis in patients with chronic heart failure. We will randomize (with a 1:1:1 ratio) patients with a confirmed diagnosis of non-ischemic chronic heart failure to undergo one of the following: 1. \- A ketogenic diet (\<50 gr of carbohydrates per day) incorporating current recommendations for heart failure (low sodium and liquids) for 10 days. 2. \- Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days. 3. \- Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo. The endpoints will be assessed using cardiac MRI and blood biomarkers.

Conditions

• Heart Failure With Reduced Ejection Fraction
• Ketosis

Interventions

Type	Name	Description
BEHAVIORAL	Ketogenic diet	A diet with \<50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats
DIETARY_SUPPLEMENT	Exogenous ketones	Administration of ketone monoester 25 ml t.i.d
BEHAVIORAL	Standard diet + placebo	A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-10-20
• Completion: 2024-12-01
• First posted: 2021-06-10
• Last updated: 2022-10-18

Locations

1 site across 1 country: Mexico