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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

Tracking Information
First Submitted Date  ICMJE May 9, 2014
First Posted Date  ICMJE May 30, 2014
Last Update Posted Date February 7, 2019
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
Oxygen saturation [ Time Frame: 2 months after intervention ]
Oxygen saturation was measured indirectly with a pulse oximeter
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
Oxygen saturation [ Time Frame: 2 months after intervention ]
Change History Complete list of historical versions of study NCT02150798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Handgrip strength [ Time Frame: 2 months after intervention ]
    Handgrip strength was evaluated with a dinamometer
  • Blood pressure [ Time Frame: 2 months after intervention ]
    Blood pressure was evaluated with an automatic sphygmomanometer
  • 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
  • Adverse effects [ Time Frame: 2 months follow-up ]
    Symptoms such as constipation, abdominal distension, nausea or diarrhea were evaluated
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
  • Handgrip strength [ Time Frame: 2 months after intervention ]
  • Blood pressure [ Time Frame: 2 months after intervention ]
  • 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
  • Lipid profile [ Time Frame: 2 months after intervention ]
  • Adverse effects [ Time Frame: 2 months follow-up ]
    Symptoms such as constipation, abdominal distension, nausea or diarrhea were evaluated
Current Other Pre-specified Outcome Measures
 (submitted: May 27, 2014)
Body composition [ Time Frame: 2 month after intervention ]
Bioimpedance parameters: resistance, reactance, phase angle, body water
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
Official Title  ICMJE The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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,
  • Other: Control diet
    Control diet. At baseline and at 2 month of following, the variables that were evaluated,
Study Arms  ICMJE
  • 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
    Intervention: Other: High fat and low carbohydrate diet
  • 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
    Intervention: Other: Control diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2014)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02150798
Other Study ID Numbers  ICMJE CLIC001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Sponsor  ICMJE Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP