High Fat Diet for Cardiac Metabolic Reprogramming

NCT06747429 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-24

No results posted yet for this study

Summary

The heart is a unique organ that performs an incessant work to pump blood throughout the body. For this massive effort, it requires a very high supply of energy. Mitochondria are small components of the cells responsible for the production of energy. To produce energy, mitochondria from cardiac cells can use fuel of different origins (fats, glucose, proteins, etc). In normal circumstances, cardiac mitochondria use preferentially fats since they are more efficient in terms of quantify of energy produced. Recent data from our consortium has demonstrated that if the cardiac mitochondria switch the primary source of fuel (from fats to glucose), this results in a poor performance of the organ, which cannot supply the whole body with enough blood. This is known as heart failure. In experimental models of heart failure, we have demonstrated that a high fat diet is able to reverse the metabolic switch and make the cardiac cells mitochondria use again fats as the primary substrate to produce energy. This translates into a recovery of heart failure. In the present project, we plan to bring this concept to the human setting and perform a pilot clinical study where patients with heart failure are put in a dietary program consisting of high fat diet. The effect of this nutritional approach will be evaluated by state-of-the-art non-invasive imaging technology.

Conditions

  • Hearth Failure Secondary to Non-ischemic DCM with Reduced LVEF (≤40%)

Interventions

OTHER

High fat diet

Weekly isocaloric dietary profile, with total daily energy intake distributed as follows: 70% from fats, primarily sourced from nuts, extra virgin olive oil, avocados, and animal fats from fish and cheese; protein intake of 0.8-1.2 g per kg body weight (10-20%); and the remaining calories from carbohydrates (10-20%).

OTHER

Standard diet

Weekly isocaloric dietary profile, with total daily energy intake distributed as follows: 30% from fats, primarily sourced from nuts, extra virgin olive oil, avocados, and animal fats from fish and cheese; protein intake of 0.8-1.2 g per kg body weight (10-20%); and 50-60% from carbohydrates.

Sponsors & Collaborators

  • INSTITUTO DE SALUD CARLOS III (ISCIII)

    collaborator UNKNOWN
  • Puerta de Hierro Majadahonda University Hospital

    collaborator UNKNOWN
  • Nicole Karam, European Hospital Georges Pompidou, Paris, France

    collaborator UNKNOWN
  • Carol Davila University of Medicine and Pharmacy Bucharest

    collaborator UNKNOWN
  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-12-31
Completion
2026-07-31

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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 NCT06747429 on ClinicalTrials.gov