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

NCT04921293 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-10-18

No results posted yet for this study

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.

Conditions

  • Heart Failure With Reduced Ejection Fraction
  • Ketosis

Interventions

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.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Adrian Soto, Ph.D, MD. · INCMNSZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-10-20
Completion
2024-12-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921293 on ClinicalTrials.gov