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The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure

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ClinicalTrials.gov Identifier: NCT02150798
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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


Condition or disease Intervention/treatment Phase
Heart Failure Other: High fat and low carbohydrate diet Other: Control diet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: High fat and low carbohydrate diet
High fat low carbohydrate diet composition was 40 % of carbohydrates, 40 % of lipids (12 % saturated, 18 % monounsaturated and 10% polyunsaturated, ) and 20 % of protein for two months
Other: High fat and low carbohydrate diet
high fat and low carbohydrate diet. At baseline and at 2 month of following, the variables that were evaluated,

Active Comparator: Control diet
the standard diet composition was 50 % of carbohydrates, 30 % of lipids (10 % saturated, 10 % polyunsaturated, and 10 % monounsaturated) and 20 % of protein for two months
Other: Control diet
Control diet. At baseline and at 2 month of following, the variables that were evaluated,




Primary Outcome Measures :
  1. Oxygen saturation [ Time Frame: 2 months after intervention ]
    Oxygen saturation was measured indirectly with a pulse oximeter


Secondary Outcome Measures :
  1. Handgrip strength [ Time Frame: 2 months after intervention ]
    Handgrip strength was evaluated with a dinamometer

  2. Blood pressure [ Time Frame: 2 months after intervention ]
    Blood pressure was evaluated with an automatic sphygmomanometer

  3. Exercise tolerance [ Time Frame: 2 months after intervention ]
    Exercise tolerance was measured in metabolic equivalents (METs) with symptom-limited treadmill exercise testing, conducted according to the modified Bruce protocol

  4. Adverse effects [ Time Frame: 2 months follow-up ]
    Symptoms such as constipation, abdominal distension, nausea or diarrhea were evaluated


Other Outcome Measures:
  1. Body composition [ Time Frame: 2 month after intervention ]
    Bioimpedance parameters: resistance, reactance, phase angle, body water



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150798


Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Dulce G Gonzalez, M.Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Director: Lilia Castillo, M.Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Director: Arturo Orea, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Chair: Gabriela Olvera, B.Sc Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Chair: Karla Balderas, B.Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Chair: Cira Santillán, M.Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Chair: Wendy Rodríguez, M.Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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Responsible Party: LILIA CASTILLO MARTINEz, at the National Institute of Medical Science and Nutrition Salvador Zubiran, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02150798     History of Changes
Other Study ID Numbers: CLIC001
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Keywords provided by LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Diet Therapy
Diet, Carbohydrate Restricted
Fatty Acids, Omega 3
Oximetry
phase angle
Triglycerides, blood
Lipids, blood
Hand Strength
Body Composition
Electric Impedance
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases