Heart FailureNCT02150798
The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
A study testing High fat and low carbohydrate diet in people with Heart Failure, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- High fat and low carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteMexico
- Study dates
- May 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of heart failure
- New York Heart Association functional classes I to III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, 14000
About this study
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
Read the 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.
- Conditions
- Heart Failure
- Being tested
- High fat and low carbohydrate diet, Control diet
- Keywords
- Diet Therapy, Diet, Carbohydrate Restricted, Fatty Acids, Omega 3, Oximetry, phase angle, Triglycerides, blood, Lipids, blood, Hand Strength, Body Composition, Electric Impedance
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat and low carbohydrate dietOther
high fat and low carbohydrate diet. At baseline and at 2 month of following, the variables that were evaluated,
Control dietOther
Control diet. At baseline and at 2 month of following, the variables that were evaluated,
| Study group | Role | What they receive |
|---|---|---|
| High fat and low carbohydrate diet | Experimental | 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 Receives: Other: High fat and low carbohydrate diet |
| Control diet | Active comparator | 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 Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
Oxygen saturation was measured indirectly with a pulse oximeter
Measured: 2 months after intervention
Secondary outcomes (4)
Handgrip strength
Handgrip strength was evaluated with a dinamometer
Measured: 2 months after intervention
Blood pressure
Blood pressure was evaluated with an automatic sphygmomanometer
Measured: 2 months after intervention
Exercise tolerance
Exercise tolerance was measured in metabolic equivalents (METs) with symptom-limited treadmill exercise testing, conducted according to the modified Bruce protocol
Measured: 2 months after intervention
Adverse effects
Symptoms such as constipation, abdominal distension, nausea or diarrhea were evaluated
Measured: 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Dulce G Gonzalez, M.Sc., Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranLilia Castillo, M.Sc., Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranArturo Orea, MD, Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranGabriela Olvera, B.Sc, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranKarla Balderas, B.Sc., Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranCira Santillán, M.Sc., Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranWendy Rodríguez, M.Sc., Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150798
- Sponsor's protocol ID
- CLIC001
- Status last verified
- Feb 2019
- First submitted
- 9 May 2014
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02150798
- Acronym / sponsor ID
- CLIC001
- Conditions
- Heart Failure
- Keywords
- Diet Therapy, Diet, Carbohydrate Restricted, Fatty Acids, Omega 3, Oximetry, phase angle, Triglycerides, blood, Lipids, blood, Hand Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat and low carbohydrate diet | Experimental | Other: High fat and low carbohydrate dietHigh 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 |
| Control diet | Active comparator | Other: Control dietthe standard diet composition was 50 % of carbohydrates, 30 % of lipids (10 % saturated, 10 % polyunsaturated, and 10 % monounsaturated) and 20 % of protein for two months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The diagnosis of heart failure
- New York Heart Association functional classes I to III
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fat and low carbohydrate diethigh fat and low carbohydrate diet. At baseline and at 2 month of following, the variables that were evaluated, | Other | High fat and low carbohydrate diet |
| Control dietControl diet. At baseline and at 2 month of following, the variables that were evaluated, | Other | Control diet |
Primary outcome
Oxygen saturation
Time frame: 2 months after intervention
Oxygen saturation was measured indirectly with a pulse oximeter
4 secondary outcomes
Handgrip strength
Time frame: 2 months after intervention
Blood pressure
Time frame: 2 months after intervention
Exercise tolerance
Time frame: 2 months after intervention
Adverse effects
Time frame: 2 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dulce G Gonzalez, M.Sc. principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lilia Castillo, M.Sc. study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Arturo Orea, MD study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat and low carbohydrate diet in people with Heart Failure, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation (time frame: 2 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.