Heart FailureNCT01423266
Effects of a High Protein Diet on Clinical Outcomes in Heart Failure
A study testing 12-week supervised weight loss intervention in people with Heart Failure and Diabetes Mellitus, run by University of California, Irvine at 1 site in United States.
Trial summary
This research project was designed to study the role of dietary modifications in heart failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically, the purpose of this study is to determine whether or not heart failure patients participating in a 3-month intensive lifestyle modification… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diabetes Mellitus
- What is being tested?
- 12-week supervised weight loss intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2015
- 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
- obese (BMI > 27 kg/m2);
- history of type 2 DM or documented impaired fasting glucose (IFG) according to fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or Metabolic Syndrome ( as defined by the International Diabetes Federation 2011
- evaluation of HF and optimization of medical therapy; and
- ischemic or idiopathic HF etiology.
Who cannot join
- age ≤18 years old;
- history of clinically significant illness including acute myocardial infarction or sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory, and/or gastrointestinal disease and malignancy;
- pregnancy or lactation;
- serum creatinine level > 1.5 mg/dl;*
- currently participating in a supervised weight loss program;
- physician refusal to permit patient participation in the study; and
- weight loss of >6% in the last 6 months
- gout or history of gout
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Medical Center
Orange, California, 92868
About this study
Official title: Examining the Effects of a High Protein Diet on Adiposity and Cardiac Structure in Patients With Heart Failure, Obesity, and Diabetes Mellitus
This research project was designed to study the role of dietary modifications in heart failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically, the purpose of this study is to determine whether or not heart failure patients participating in a 3-month intensive lifestyle modification program of either a high protein (30 % of total calories from protein) group will have a significant improvement in weight reduction, quality of life and clinical outcomes compared to a standardized protein (15% of total calories from protein) group.
Read the detailed description
Clinical management of heart failure (HF) related to obesity and diet recommendations currently lacks a strong scientific basis, and clinicians are divided in their approach to diet recommendations for this patient population. It has been shown that in extremely obese HF patients, weight reduction improves cardiac structure and function as well as functional status and symptomatology. Evidence on the impact of voluntary weight loss on improvement in survival in obese HF patients, however, is limited.
The purpose of this study is to determine whether or not heart failure patients participating in a 3-month intensive lifestyle modification program of either a high protein (30% of total calories from protein) group will have a significant improvement in weight reduction, quality of life and clinical outcomes compared to a standardized protein (15% of total calories from protein) group.
In addition to dietary interventions, participants in both groups with be given an exercise prescription and encouraged to exercise for 20-30 minutes at least 3-5 times each week as tolerated. They will also continue to receive usual medical care, advice and other support for their condition from their cardiologist or medical physician. Both sets of participants will utilize self-monitoring tools to assist with diet compliance and behavior change. These self-monitoring tools are mandatory and will be collected and analyzed. At each visit, subjects will also be asked to will also be asked to have their weight and waist circumference measured and, at select visits, they will provide a 24 hour recall to assess fullness with the overall diet. Subjects will be given a 3-day food (3DFR) record at baseline, which will be returned at the the 2-week, 4- week and 8-week visits, and will also complete the 3DFR at three months.
- Conditions
- Heart Failure, Diabetes Mellitus
- Being tested
- 12-week supervised weight loss intervention
- Keywords
- High Protein Diet in heart failure, obesity and heart failure, Weight management in Heart failure, heart failure, diabetes and obesity
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week supervised weight loss interventionProcedure or surgery
Also called weight management, diet, nutritional supervision
Patients in the 2 study arms will participate in an intensive 12-week supervised weight loss intervention and will be seen by the same dietician at regular intervals: baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. Participants will receive personalized nutrition counseling and support during each of these visits. Participants will be randomized to either the HP or SP diet and assigned to receive one of two standard structured energy-restricted meal plans (1200, 1500 Kcal/day) based on the computed calorie deficit
| Study group | Role | What they receive |
|---|---|---|
| High Protein Group | Experimental | 12-week supervised weight loss program consisting of a HP diet defined as 30% of energy from protein, 40% from carbohydrates and 30% from fat Receives: Procedure: 12-week supervised weight loss intervention |
| Standard Protein Group | Active comparator | 12-week supervised weight loss program consisting of a SP diet defined as 15% of energy from protein, 55% from carbohydrates and 30% from fat Receives: Procedure: 12-week supervised weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in adiposity (and body composition; i.e., % body fat))
Measured: 3 months and 15 months
Secondary outcomes (4)
Change from Baseline in lipid profiles (while controlling for statin drug dosage)
Measured: 3 months and 15 months
Change from Baseline in glycemic control and insulin resistance
Measured: 3 months and 15 months
Change from Baseline in peripheral blood circulation (as measured using peripheral arterial tonometry and plasma nitroxide measurement)
Measured: 3 months and 15 months
Change from Baseline in levels of quality of life
Measured: 3 months and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Lorraine Evangelista, University of California, Irvine
- Investigators
- Lorraine S Evangelista, PhD,RN,FAAN, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423266
- Sponsor's protocol ID
- 1R01HL093466-01
- Status last verified
- May 2016
- First submitted
- 15 Aug 2011
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data management and analysis is in progress.
Publications
Evangelista LS, Nguyen AP, Kawi J, Meraz R, Wierenga KL, Angosta AD, Hamilton MA, Fonarow GC. Racial and Ethnic Differences in Dietary Intake and Metabolic Profiles Among Adults with Heart Failure, Type 2 Diabetes, and Overweight or Obesity: A Secondary Analysis of the Pro-HEART Trial. Nutrients. 2026 Aug 21;18(16):2737. doi: 10.3390/nu18162737.
PubMed 42654317Reyes AT, Nguyen A, Angosta AD, Meraz R, Wierenga KL, Kawi J, Evangelista LS. Patient-Reported Barriers to Dietary Adherence in Heart Failure: A Qualitative Substudy of the Pro-HEART Trial. Eur J Cardiovasc Nurs. 2026 Mar 30:zvag092. doi: 10.1093/eurjcn/zvag092. Online ahead of print.
PubMed 41911329
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of a High Protein Diet on Adiposity and Cardiac Structure in Patients With Heart Failure, Obesity, and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01423266
- Acronym / sponsor ID
- 1R01HL093466-01
- Conditions
- Heart Failure, Diabetes Mellitus
- Keywords
- High Protein Diet in heart failure, obesity and heart failure, Weight management in Heart failure, heart failure, diabetes and obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Dec 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2011 (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.
This research project was designed to study the role of dietary modifications in heart failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically, the purpose of this study is to determine whether or not heart failure patients participating in a 3-month intensive lifestyle modification program of either a high protein (30 % of total calories from protein) group will have a significant improvement in weight reduction, quality of life and clinical outcomes compared to a standardized protein (15% of total calories from protein) group.
Detailed description
Clinical management of heart failure (HF) related to obesity and diet recommendations currently lacks a strong scientific basis, and clinicians are divided in their approach to diet recommendations for this patient population. It has been shown that in extremely obese HF patients, weight reduction improves cardiac structure and function as well as functional status and symptomatology. Evidence on the impact of voluntary weight loss on improvement in survival in obese HF patients, however, is limited.
The purpose of this study is to determine whether or not heart failure patients participating in a 3-month intensive lifestyle modification program of either a high protein (30% of total calories from protein) group will have a significant improvement in weight reduction, quality of life and clinical outcomes compared to a standardized protein (15% of total calories from protein) group.
In addition to dietary interventions, participants in both groups with be given an exercise prescription and encouraged to exercise for 20-30 minutes at least 3-5 times each week as tolerated. They will also continue to receive usual medical care, advice and other support for their condition from their cardiologist or medical physician. Both sets of participants will utilize self-monitoring tools to assist with diet compliance and behavior change. These self-monitoring tools are mandatory and will be collected and analyzed. At each visit, subjects will also be asked to will also be asked to have their weight and waist circumference measured and, at select visits, they will provide a 24 hour recall to assess fullness with the overall diet. Subjects will be given a 3-day food (3DFR) record at baseline, which will be returned at the the 2-week, 4- week and 8-week visits, and will also complete the 3DFR at three months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein Group | Experimental | Procedure: 12-week supervised weight loss intervention12-week supervised weight loss program consisting of a HP diet defined as 30% of energy from protein, 40% from carbohydrates and 30% from fat |
| Standard Protein Group | Active comparator | Procedure: 12-week supervised weight loss intervention12-week supervised weight loss program consisting of a SP diet defined as 15% of energy from protein, 55% from carbohydrates and 30% from fat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- obese (BMI > 27 kg/m2);
- history of type 2 DM or documented impaired fasting glucose (IFG) according to fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or Metabolic Syndrome ( as defined by the International Diabetes Federation 2011
- evaluation of HF and optimization of medical therapy; and
- ischemic or idiopathic HF etiology.
Key exclusion criteria (8 listed)
- age ≤18 years old;
- history of clinically significant illness including acute myocardial infarction or sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory, and/or gastrointestinal disease and malignancy;
- pregnancy or lactation;
- serum creatinine level > 1.5 mg/dl;*
- currently participating in a supervised weight loss program;
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 |
|---|---|---|
| 12-week supervised weight loss interventionAlso: weight management, diet, nutritional supervisionPatients in the 2 study arms will participate in an intensive 12-week supervised weight loss intervention and will be seen by the same dietician at regular intervals: baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. Participants will receive personalized nutrition counseling and support during each of these visits. Participants will be randomized to either the HP or SP diet and assigned to receive one of two standard structured energy-restricted meal plans (1200, 1500 Kcal/day) based on the computed calorie deficit | Procedure or surgery | High Protein Group, Standard Protein Group |
Primary outcome
Change from Baseline in adiposity (and body composition; i.e., % body fat))
Time frame: 3 months and 15 months
4 secondary outcomes
Change from Baseline in lipid profiles (while controlling for statin drug dosage)
Time frame: 3 months and 15 months
Change from Baseline in glycemic control and insulin resistance
Time frame: 3 months and 15 months
Change from Baseline in peripheral blood circulation (as measured using peripheral arterial tonometry and plasma nitroxide measurement)
Time frame: 3 months and 15 months
Change from Baseline in levels of quality of life
Time frame: 3 months and 15 months
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 23 May 2016.
- Derived from this study: PubMed 42654317Evangelista LS, Nguyen AP, Kawi J, Meraz R, Wierenga KL, Angosta AD, Hamilton MA, Fonarow GC. Racial and Ethnic Differences in Dietary Intake and Metabolic Profiles Among Adults with Heart Failure, Type 2 Diabetes, and Overweight or Obesity: A Secondary Analysis of the Pro-HEART Trial. Nutrients. 2026 Aug 21;18(16):2737. doi: 10.3390/nu18162737.
- Derived from this study: PubMed 41911329Reyes AT, Nguyen A, Angosta AD, Meraz R, Wierenga KL, Kawi J, Evangelista LS. Patient-Reported Barriers to Dietary Adherence in Heart Failure: A Qualitative Substudy of the Pro-HEART Trial. Eur J Cardiovasc Nurs. 2026 Mar 30:zvag092. doi: 10.1093/eurjcn/zvag092. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data management and analysis is in progress.
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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.
Lorraine S Evangelista, PhD,RN,FAAN principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week supervised weight loss intervention in people with Heart Failure and Diabetes Mellitus, run by University of California, Irvine at 1 site in United States.
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 4 inclusion and 8 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 23 May 2016. 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 United States. 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?
Change from Baseline in adiposity (and body composition; i.e., % body fat)) (time frame: 3 months and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423266, which also lists 2 linked publications.
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 23 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.