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Nutritional Ketosis in Heart Failure

NCT04370600 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-05-01

No results posted yet for this study

Summary

Chronic, ambulatory heart failure patients will be given ketone ester dietary supplementation to determine therapeutic efficacy, metabolic adaptation, pharmacokinetics, associated cognitive changes, and safety within this patient cohort in order to establish preliminary data to later conduct a multi-center randomized clinical trial.

Conditions

Interventions

DRUG

beta hydroxybutyrate (BHB) ester

Ketone supplementation given 3x/day (60mL per dose, or 22g BHB)

DRUG

Placebo

Denatonium benzoate + HVMN ketone placebo flavor mix + Stevia

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • J. Eduardo Rame, M.D. · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-06-30
Completion
2021-06-30

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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 NCT04370600 on ClinicalTrials.gov