Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction
NCT ID: NCT04921293
Last Updated: 2022-10-18
Study Results
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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UNKNOWN
NA
18 participants
INTERVENTIONAL
2023-06-01
2024-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Diet
Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.
Standard diet + placebo
A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.
Endogenous Ketosis
Ketogenic diet incorporating current recommendations for heart failure (\<50gr of carbohydrates, low sodium, and liquids) for 10 days.
Ketogenic diet
A diet with \<50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats
Exogenous ketosis
Standard incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.
Exogenous ketones
Administration of ketone monoester 25 ml t.i.d
Interventions
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Ketogenic diet
A diet with \<50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats
Exogenous ketones
Administration of ketone monoester 25 ml t.i.d
Standard diet + placebo
A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.
Eligibility Criteria
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Inclusion Criteria
* No change in optimum treatment 1 month at least.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Principal Investigators
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Adrian Soto, Ph.D, MD.
Role: PRINCIPAL_INVESTIGATOR
INCMNSZ
Locations
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INCMNSZ
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UIE-3652-21-22-1
Identifier Type: -
Identifier Source: org_study_id
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