NCT04921293

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
2 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 18, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

June 2, 2021

Last Update Submit

October 17, 2022

Conditions

Heart Failure With Reduced Ejection FractionKetosis

Keywords

Endogenous ketosisExogenous ketosisHeart failure

Outcome Measures

Primary Outcomes (1)

  • Ejection fraction Improvement

    Estimated by cardiac MRI

    10 days

Secondary Outcomes (3)

  • Clinical severity

    10 days

  • Liquid retention

    10 days

  • Blood biomarker

    10 days

Study Arms (3)

Standard Diet

ACTIVE COMPARATOR

Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.

Behavioral: Standard diet + placebo

Endogenous Ketosis

EXPERIMENTAL

Ketogenic diet incorporating current recommendations for heart failure (\<50gr of carbohydrates, low sodium, and liquids) for 10 days.

Behavioral: Ketogenic diet

Exogenous ketosis

EXPERIMENTAL

Standard incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.

Dietary Supplement: Exogenous ketones

Interventions

Ketogenic dietBEHAVIORAL

A diet with \<50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats

Endogenous Ketosis
Exogenous ketonesDIETARY_SUPPLEMENT

Administration of ketone monoester 25 ml t.i.d

Exogenous ketosis
Standard diet + placeboBEHAVIORAL

A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.

Standard Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ejection fraction \<40% minimum 1 month.
  • No change in optimum treatment 1 month at least.

You may not qualify if:

  • Ischemic cardiopathy (Angio-tomography corroborated cut-point \>50% obstruction, coronary angiography, or cardiac scintigraphy 6 months at least) or angina pectoris symptoms.
  • Reynaud syndrome
  • Metformin or SGLT-2 Inhibitors treatment, Low BMI, nutritional deficiencies.
  • Creatinin clearance \<30ml/min or renal replacement therapy
  • MRI contraindications (prothesis, Unsupported pacemakers, claustrophobia, etc)
  • Reynaud phenomenon history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCMNSZ

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (8)

  • Astrup A, Magkos F, Bier DM, Brenna JT, de Oliveira Otto MC, Hill JO, King JC, Mente A, Ordovas JM, Volek JS, Yusuf S, Krauss RM. Saturated Fats and Health: A Reassessment and Proposal for Food-Based Recommendations: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Aug 18;76(7):844-857. doi: 10.1016/j.jacc.2020.05.077. Epub 2020 Jun 17.

    PMID: 32562735BACKGROUND

  • Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.

    PMID: 31231311BACKGROUND

  • Aubert G, Martin OJ, Horton JL, Lai L, Vega RB, Leone TC, Koves T, Gardell SJ, Kruger M, Hoppel CL, Lewandowski ED, Crawford PA, Muoio DM, Kelly DP. The Failing Heart Relies on Ketone Bodies as a Fuel. Circulation. 2016 Feb 23;133(8):698-705. doi: 10.1161/CIRCULATIONAHA.115.017355. Epub 2016 Jan 27.

    PMID: 26819376BACKGROUND

  • Bertero E, Maack C. Metabolic remodelling in heart failure. Nat Rev Cardiol. 2018 Aug;15(8):457-470. doi: 10.1038/s41569-018-0044-6.

    PMID: 29915254BACKGROUND

  • Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459.

    PMID: 30884964BACKGROUND

  • Norwitz NG, Loh V. A Standard Lipid Panel Is Insufficient for the Care of a Patient on a High-Fat, Low-Carbohydrate Ketogenic Diet. Front Med (Lausanne). 2020 Apr 15;7:97. doi: 10.3389/fmed.2020.00097. eCollection 2020.

    PMID: 32351962BACKGROUND

  • Soto-Mota A, Vansant H, Evans RD, Clarke K. Safety and tolerability of sustained exogenous ketosis using ketone monoester drinks for 28 days in healthy adults. Regul Toxicol Pharmacol. 2019 Dec;109:104506. doi: 10.1016/j.yrtph.2019.104506. Epub 2019 Oct 23.

    PMID: 31655093BACKGROUND

  • Soto-Mota A, Norwitz NG, Clarke K. Why a d-beta-hydroxybutyrate monoester? Biochem Soc Trans. 2020 Feb 28;48(1):51-59. doi: 10.1042/BST20190240.

    PMID: 32096539BACKGROUND

MeSH Terms

Conditions

KetosisHeart Failure

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Adrian Soto, Ph.D, MD.

    INCMNSZ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Soto, Ph.D, MD.

CONTACT

5572191248adrian.sotom@incmnsz.mx

Jorge Oseguera, MD

CONTACT

54870900jorge.osegueram@incmnsz.mx

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 10, 2021

Study Start

June 1, 2023

Primary Completion

October 20, 2024

Study Completion

December 1, 2024

Last Updated

October 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Upon request to PI

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
One year after publication
Access Criteria
Send email to adrian.sotom@incmnsz.mx

Locations

ME(1)