The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
High fat and low carbohydrate diet
Control diet
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Diet Therapy, Diet, Carbohydrate Restricted, Fatty Acids, Omega 3, Oximetry, phase angle, Triglycerides, blood, Lipids, blood, Hand Strength, Body Composition, Electric Impedance
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
Sites / Locations
- Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High fat and low carbohydrate diet
Control diet
Arm Description
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
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
Outcomes
Primary Outcome Measures
Oxygen saturation
Oxygen saturation was measured indirectly with a pulse oximeter
Secondary Outcome Measures
Handgrip strength
Handgrip strength was evaluated with a dinamometer
Blood pressure
Blood pressure was evaluated with an automatic sphygmomanometer
Exercise tolerance
Exercise tolerance was measured in metabolic equivalents (METs) with symptom-limited treadmill exercise testing, conducted according to the modified Bruce protocol
Adverse effects
Symptoms such as constipation, abdominal distension, nausea or diarrhea were evaluated
Full Information
NCT ID
NCT02150798
First Posted
May 9, 2014
Last Updated
February 5, 2019
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT02150798
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High fat and low carbohydrate diet
Arm Type
Experimental
Arm Description
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
Arm Title
Control diet
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
High fat and low carbohydrate diet
Intervention Description
high fat and low carbohydrate diet. At baseline and at 2 month of following, the variables that were evaluated,
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
Control diet. At baseline and at 2 month of following, the variables that were evaluated,
Primary Outcome Measure Information:
Title
Oxygen saturation
Description
Oxygen saturation was measured indirectly with a pulse oximeter
Time Frame
2 months after intervention
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Handgrip strength was evaluated with a dinamometer
Time Frame
2 months after intervention
Title
Blood pressure
Description
Blood pressure was evaluated with an automatic sphygmomanometer
Time Frame
2 months after intervention
Title
Exercise tolerance
Description
Exercise tolerance was measured in metabolic equivalents (METs) with symptom-limited treadmill exercise testing, conducted according to the modified Bruce protocol
Time Frame
2 months after intervention
Title
Adverse effects
Description
Symptoms such as constipation, abdominal distension, nausea or diarrhea were evaluated
Time Frame
2 months follow-up
Other Pre-specified Outcome Measures:
Title
Body composition
Description
Bioimpedance parameters: resistance, reactance, phase angle, body water
Time Frame
2 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dulce G Gonzalez, M.Sc.
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lilia Castillo, M.Sc.
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arturo Orea, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gabriela Olvera, B.Sc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karla Balderas, B.Sc.
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cira Santillán, M.Sc.
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wendy Rodríguez, M.Sc.
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
We'll reach out to this number within 24 hrs