Clinical trial NCT02150798: The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
Official title: The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Diet Therapy
Diet, Carbohydrate Restricted
Fatty Acids, Omega 3
Oximetry
phase angle
Triglycerides, blood
Lipids, blood
Hand Strength
Body Composition
Electric Impedance
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate the effects of a high fat, low carbohydrate (CHO) diet on clinical status during 60 days of follow-up in patients with stable heart failure (HF).

In a randomized controlled clinical trial 44 ambulatory patients with HF were included, assigned to an intervention (40% CHO, 40% fat and 20% protein; n=22) or control groups (50% CHO, 30% fat, 20% protein; n=20). Both groups received recommended pharmacological management. At baseline and at 2 months of follow-up, the variables evaluated were: body composition, handgrip strength, oxygen saturation, dietary intake, clinical data, lipid profile, plasma glucose and exercise tolerance

Detailed description: Nutritional therapy in patients with heart failure (HF) has been focused on fluid and sodium restriction to decrease volume overload. This has proved to decrease extracellular water levels, which manifests as a reduction in edema. Also, in patients with HF and preserved ejection fraction, reduction of sodium in addition to the Dietary Approaches to Stop Hypertension (DASH) diet has been associated with improved left ventricular diastolic function and arterial elasticity, reduced blood pressure, and modestly lower mortality in HF women.

Some studies focused on reducing cardiovascular risk suggest that saturated fatty acids should be replaced by some other macronutrient. Clinical trials which evaluated the replacement of saturated fatty acids with monounsaturated or polyunsaturated fatty acids have found an improvement in blood lipid concentrations and reduced cardiovascular risk in different populations. In the case of omega (n)-3 polyunsaturated fatty acids (PUFA), antiarrhythmic, antithrombotic, anti-atherogenic, and anti-inflammatory effects , improvement of endothelial function, lower blood pressure and plasma triglycerides, and reduced mortality and admission to the hospital for cardiovascular reasons have been documented in patients with chronic heart failure. In addition, the Mediterranean diet, which is high in monounsaturated fatty acids, was associated with cardiovascular risk reduction in other populations.

In HF PUFA was associated with better systolic and diastolic function, but with no effect on mortality. On the other hand, the replacement of saturated fatty acids by carbohydrates must be considered responsible for the possible increase in total cholesterol, LDL cholesterol (LDL-c), plasma triglycerides and decreased HDL cholesterol. Furthermore, the metabolism of carbohydrates induces higher oxygen consumption (VO2), higher carbon dioxide (VCO2) production and increased minute ventilation (VE). In other populations, it has been associated with lower respiratory efficiency and decreased exercise tolerance.

HF should be considered a complex condition in which the heart fails to deliver enough oxygen-rich blood to meet the body's needs, and these patients characteristically have skeletal muscle dysfunction and compromised pulmonary function and ventilatory response, with peak oxygen consumption reduced and deterioration of their clinical state.

Nonetheless, nutritional therapy of HF patients has not been focused on optimizing mechanical ventilation with improved consumption of oxygen. Moreover, studies that examine nutritional therapy in HF have not evaluated the ventilatory response. Therefore, we propose to evaluate the effects of a high fat and low carbohydrate diet on clinical status of chronic stable HF patients.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of heart failure
* New York Heart Association functional classes I to III

Exclusion Criteria:

* New Year Heart Association functional classes IV symptoms
* Patients with severe renal insufficiency (estimated glomerular filtration rate \<30 mL/min per 1.73 m2) - Patients with hepatic failure
* Patients with specific dietary regimen

Primary outcomes:
measure: Oxygen saturation
timeFrame: 2 months after intervention
Secondary outcomes:
measure: Handgrip strength
timeFrame: 2 months after intervention
measure: Blood pressure
timeFrame: 2 months after intervention
measure: Exercise tolerance
timeFrame: 2 months after intervention
measure: Adverse effects
timeFrame: 2 months follow-up
Other outcomes:
measure: Body composition
timeFrame: 2 month after intervention
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Dulce G Gonzalez, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Lilia Castillo, M.Sc.
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Arturo Orea, MD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Gabriela Olvera, B.Sc
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Karla Balderas, B.Sc.
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Cira Santillán, M.Sc.
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Wendy Rodríguez, M.Sc.
role: STUDY_CHAIR
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