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Completed

NCT Number: NCT01423266

Effects of a High Protein Diet on Clinical Outcomes in Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

12-week supervised weight loss intervention

Procedure

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

Other names: weight management, diet, nutritional supervision

Primary outcomes

  1. Change from Baseline in adiposity (and body composition; i.e., % body fat))

    Time frame: 3 months and 15 months

Secondary outcomes

  1. Change from Baseline in lipid profiles (while controlling for statin drug dosage)

    Time frame: 3 months and 15 months

  2. Change from Baseline in glycemic control and insulin resistance

    Time frame: 3 months and 15 months

  3. Change from Baseline in peripheral blood circulation (as measured using peripheral arterial tonometry and plasma nitroxide measurement)

    Time frame: 3 months and 15 months

  4. Change from Baseline in levels of quality of life

    Time frame: 3 months and 15 months

Other outcomes

  1. Change in Cardiac Structure

    Time frame: 3 months and 15 months

  2. Change in Cardiac Function

    Time frame: 3 months and 15 months

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

Examining the Effects of a High Protein Diet on Adiposity and Cardiac Structure in Patients With Heart Failure, Obesity, and Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2011
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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